field_job_employment_type

field_job_occupational_field_parents_all

job_organization_name

city

state

<h3>Job Description</h3>
Job Description
About DeepSight Technology 
DeepSight Technology is a leading innovator in medical device technology, specializing in advanced ultrasound solutions like enhanced needle guidance with NeedleVue™, high-resolution imaging from the tip of a needle with OnPoint™ Imaging, and superior diagnostic capability with the EchoLux™ Ultrasound system. Our mission is to revolutionize patient care through state-of-the-art systems, oIering unprecedented precision and accuracy for healthcare providers. 
Job Summary 
The Instrument Engineer will lead the design, prototyping, and optimization of DeepSight's interventional instruments. This role takes concepts from ideation to prototype, ensuring seamless integration into clinical applications. The ideal candidate excels in medical device development, rapid prototyping, and regulatory compliance, working cross-functionally with R&amp;D, clinical, and manufacturing teams. 
Key Responsibilities 
<ul>
<li> Develop interventional devices such as catheters, guidewires, venous access tools, biopsy instruments, and therapy delivery systems. </li>
<li> Design, prototype, and test instruments, fixtures, and assemblies. </li>
<li> Build and iterate proof-of-concept devices for pre-clinical testing. </li>
<li> Initiate and maintain the Device Master Record through development, including:</li>
</ul>
<ul>
<li>Drawings, specifications, and BOMs </li>
<li>Process instructions, test methods, and specifications </li>
<li>Fixtures, tooling, and material selection </li>
</ul>
<ul>
<li> Identify and collaborate with contract manufacturers and suppliers for sub-assemblies and production. </li>
<li> Work with clinical experts to ensure procedural requirements and constraints are incorporated into the instrument design. </li>
<li> Apply expertise in Advanced Manufacturing Techniques: </li>
</ul>
<ul>
<li>Lamination, extrusions, coiling, and braiding </li>
<li>Steering and bending sections </li>
<li>Bonding, adhesion technologies, and techniques </li>
<li>Laser cutting, welding of fine structures, EDM, and water jet machining </li>
</ul>
<ul>
<li> Ensure compliance with ISO 13485, ISO 60601, ASTM, and other relevant standards. </li>
<li> Develop and refine work instructions for designs, ensuring eIective communication with technicians. </li>
</ul>
Qualifications
<ul>
<li> B.S. or M.S. in Mechanical or Biomedical Engineering or related field. </li>
<li> 10+ years of experience in instrument engineering or medical device development. </li>
<li> Proficiency in CAD for device design and documentation. </li>
<li> Experience with medical device fabrication techniques (lamination, laser cutting, bonding, etc.). </li>
<li> Knowledge of interventional devices (catheters, guidewires, biopsy tools, etc.). </li>
<li> Familiarity with regulatory standards (ISO 13485, ISO 60601, ASTM). </li>
<li> Strong hands-on prototyping skills and ability to rapidly iterate designs. </li>
<li> Experience collaborating with contract manufacturers and suppliers. </li>
<li> Excellent problem-solving and cross-functional collaboration skills. </li>
</ul>
Why Join DeepSight? 
At DeepSight Technology, you'll be part of a team that's pushing the boundaries of ultrasound imaging and medical device innovation. This is an opportunity to develop groundbreaking instrumentation, collaborate with top engineers and clinicians, and impact the future of healthcare.
 Job Posted by ApplicantPro

Instrument Engineer

<h3>Job Description</h3>
Job Description
 ABOUT ORGANOX:
OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company’s first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.
Position Summary
The position of Senior Process Engineer will work in the US Operations Department and is responsible for US Supply Chain, Operations and Logistics activities by working on the Continuous Improvement Projects that are identified. This will be achieved by designing, documenting, implementing and optimizing departmental processes used for operations, logistics and inventory management.
The Senior Process Engineer has the following key areas of responsibility:
• Design, analyze and implement operational workflows across US operations and supply chain.
• Identify opportunities for process improvements and participate in continuous improvement initiatives.
• Develop and maintain technical process documentation, including Standard Operating Procedures, Work Instructions and Process Maps.
• Gather and report process metrics.
Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the job holder will be expected to complete tasks reasonably requested by the Senior Manager, Operations. This is a flexible, on-site role in our Madison, NJ office.
Major Responsibilities
Under direction from the Senior Manager, Operations, the Senior Process Engineer will be responsible for:
• Develop and maintain procedures that ensure compliance to ISO13485 for Operations Projects that fall under the scope of the OrganOx Quality Management System (QMS).
• Create and review Specifications, Standard Operating Procedures and Work Instructions.
• Work closely with the Regulatory Affairs and Quality departments to ensure compliance with relevant medical device regulations.
• Create and review Change Controls (CCs), Risk Assessments (RAs), Root Cause Analysis investigations, Supplier Corrective Action Reports (SCARs), Nonconformance Reports (NCs), Corrective and Preventive Actions (CAPAs) and other internal &amp; external documentation needed to support US Operations.
• Work collaboratively with colleagues at all levels in all departments to improve current processes and develop a culture of continuous improvement.
• Participate in the execution of US Operations Projects and work with cross functional teams to ensure successful execution.
• Support implementation of continuous improvement opportunities throughout the scope of operation for OrganOx Inc with the objective of improving Safety, Quality, Delivery performance and Cost.
• Collect and analyze process data and recommend improvements.
Skills &amp; Experience
• A hands-on approach to developing, evaluating, and improving processes.
• The ability to evaluate, explain and simplify complex issues.
• Proven strong knowledge and understanding of process principles and engineering techniques.
• Previous experience in writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer.
• Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
• Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans.
• Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent).
• Strong and concise communication skills, both verbal and written.
• Ability to work effectively with outside suppliers and manufacturers.
• Self-motivated and driven to succeed.
• Very strong collaborative skills.
• Ability to work across a wide range of projects simultaneously.
• Ability to work well in teams.
• Willing and able to travel globally. (Up to 10%).
Requirements
• A hands-on approach to developing, evaluating, and improving processes.
• The ability to evaluate, explain and simplify complex issues.
• Proven strong knowledge and understanding of process principles and engineering techniques.
• Previous experience in writing clear and concise Work Instructions, Standard Operation Procedures and other relevant Quality Documentation; acting as a Quality Technical writer.
• Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
• Experience with validation protocols (IQ/OQ/PQ), FMEA, and control plans.
• Proficiency in project management tools (e.g, MS Project, Smartsheet, or equivalent).
• Strong and concise communication skills, both verbal and written.
• Ability to work effectively with outside suppliers and manufacturers.
• Self-motivated and driven to succeed.
• Very strong collaborative skills.
• Ability to work across a wide range of projects simultaneously.
• Ability to work well in teams.
• Willing and able to travel globally. (Up to 10%).
Qualifications
• Bachelor’s Degree in Process, Manufacturing, Biomedical, Industrial and Systems Engineering or related field required; master’s degree preferred.
• Minimum 7 years of experience in process development, design and process implementation required.
• Strong Project Management skills.
• Previous experience in supply chain and operations preferred.
• Experience in the medical device industry preferred.
• Good working knowledge of the Safety, Quality and Regulatory Standards (ISO 14971, IEC 60601, ISO 13485 etc.) required.
• Good working knowledge or qualifications in improvement methodologies such as Lean or Six Sigma (Green Belt preferred).
• Good working knowledge or qualifications in process Design &amp; Review (DFx) preferred.
• Ability to travel up to 10% of the time domestically and globally.
Benefits
We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts. Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility. OrganOx supports work-life balance and provides opportunities for ongoing professional development.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.
Revision

Senior Process Engineer

<h3>Job Description</h3>
Job Description
Job Description:
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Reporting to Chief Technical Officer
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Looking for a creative developer excited by the prospect of bringing novel biotechnology to market in a fast-paced start-up environment.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; The successful candidate will lead the mechanical development team of the Proteowise instrument and the disposable fluidic devices that go with it.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Responsibility extends from breadboards and prototypes through close involvement with the manufacturing teams who will implement the candidate’s designs into commercial products.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be hands-on with prototypes and evaluate their designs in the lab.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the internal cross-functional development team of Software Engineers, Electrical Engineers, Optical Engineers, Biologists and Chemists to ensure systems are successfully implemented.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the Manufacturing and Quality teams to transfer manufacturable designs.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Will work closely with the Industrial design partner to faithfully implement the Proteowise vision.
Skill &amp; Experience Requirements:
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be fluent in the design and debugging methods of mechanical systems, and capable of producing mechanical parts and subsystems in house and using 3rd party suppliers.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Must be expert in Solidworks.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Experience with fluidic analyses and simulations a plus.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Successful track record of commercial launch, especially launching fluidic, microfluid disposables a plus
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; BS Mechanical or BS Biomedical Engineer. MS or PhD a plus.
·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; 5 years industry experience. More a plus.

Lead Mechanical Engineer

<h3>Job Description</h3>
Job DescriptionCompany OverviewEmbark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and&nbsp;are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities. The Opportunity That Awaits You:&nbsp;&nbsp; Do you want to be part of an innovative, cutting edge technology, robotics company that is changing how BPH is treated?&nbsp; Are you looking to be part of an enthusiastic, driven, passionate and challenging team, who continuously learn from one another?&nbsp; Are you a leader who wants to make a difference and improve processes? Are you detailed-oriented? At PROCEPT BioRobotics you will have an opportunity to contribute and greatly support our continuous improvement philosophy by being part of our Quality Engineering team. This position has a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.What Your Day-to-Day Will Involve
<ul>
<li>Quality Operations &amp; Compliance</li>
<li>Support manufacturing operations by ensuring compliance with FDA 21 CFR Part 820, ISO 13485, and ISO 14971.</li>
<li>Perform line clearance, in-process inspections, and final release activities under guidance from senior engineers.</li>
<li>Assist with nonconformance investigations (NCMRs), including data collection, basic root cause analysis, and documentation.</li>
<li>Support cleanroom controls and environmental monitoring activities to maintain compliance with Class 8 cleanroom requirements.</li>
<li>Assist with execution of process validations (IQ, OQ,PQ) and data analysis for validation and qualification activities.</li>
<li>Continuous Improvement &amp; Risk Management</li>
<li>Participate in risk management activities (e.g.,pFMEA updates, control plan reviews) under the direction of senior engineers.</li>
<li>Identify and communicate potential quality issues or process improvements to reduce defects and improve yield.</li>
<li>Support cross-functional teams in resolving day-to-day quality and production challenges. Regulatory &amp; Documentation</li>
<li>Maintain accurate and complete quality documentation, including inspection records, work instructions, and quality procedures.</li>
<li>Support internal and external audits (FDA, ISO, MDSAP) by preparing records and assisting with audit responses.</li>
<li>Assist with new product introduction (NPI) activities by supporting design transfer and process validation requirements.</li>
</ul>
The Qualifications We Need You to Possess
<ul>
<li>Bachelor’s degree in Engineering (Mechanical, Biomedical, Industrial, or related field), Life Sciences, or equivalent experience.</li>
<li>1–3 years of experience in quality, manufacturing, or engineering in a regulated environment (medical device preferred).</li>
<li>Familiarity with ISO 13485 and FDA 21 CFR Part 820 requirements.</li>
<li>Basic understanding of root cause analysis tools (e.g., 5-Why, fishbone) and nonconformance investigations.</li>
<li>Ability to read and interpret engineering drawings and use basic metrology tools (calipers, micrometers).</li>
</ul>
Preferred Skills:
<ul>
<li>Experience in medical device manufacturing (Class II or III devices).</li>
<li>Knowledge of process validation (IQ, OQ, PQ) and statistical tools (SPC, Gage R&amp;R, AQL).</li>
<li>Experience with MES or eDHR systems.</li>
<li>Exposure to cleanroom operations and environmental monitoring.</li>
</ul>
Compensation also includes a 10% annual bonus, flexible time off, and RSUs at offer!Work Authorization Status: Citizen / Permanent ResidentUnderstanding PROCEPT's CultureAt PROCEPT, we believe every person matters. Every employee, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with pathological optimism. We believe in being humble and highly engaged in the work we do, while also working together seamlessly for a common goal. At Procept, curiosity, ingenuity and conviction in the power technology will transform the lives of our patients and providers.&nbsp;And this doesn’t happen by accident. It starts with our live induction program that serves as an incubator for cross-functional team building, an immersion in Procept’s history, jam-packed interactive sessions with executive leadership and a crash-course in the mission and purpose of what we do. It continues with our one-of-a-kind management program designed to build the best managers in the industry, where our people managers across functions come together to exchange ideas and grow, as both managers and learners, in an environment that challenges, supports and broadens.&nbsp;We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU! At Procept, we push beyond just finding a work/life balance, we strive to find a work/life blend, a professional world that you are honored and impassioned to belong to, one that you can proudly share with your family, friends, and acquaintances. &nbsp;An opportunity at PROCEPT BioRobotics won’t just be about finding a job. It will be an opportunity for you to join a community devoted to making a difference in this world!&nbsp;BENEFITS OF WORKING AT PROCEPT!&nbsp;PROCEPT’s health and wellness benefits for employees are second to none in the industry. As an organization, one of our top priorities is to maintain the health and wellbeing of our employees and their families. We offer a comprehensive benefits package that includes full medical coverage, wellness programs, on-site gym, a 401(k) plan with employer match, short-term and long-term disability coverage, basic life insurance, wellbeing benefits, flexible or paid time off, paid parental leave, paid holidays, and many more! EQUAL EMPLOYMENT OPPORTUNITY STATEMENTPROCEPT BioRobotics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.&nbsp;PAY RANGE TRANSPARENCYProcept is committed to fair and equitable compensation practices. The pay range(s) for this role represents a base salary range for non-commissionable roles or on-target earnings for commissionable roles. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, relevant certifications and training, and specific work location. Based on the factors above, Procept utilizes the full width of the range. The total compensation package for this position may also include eligibility for annual performance bonus, equity, and the benefits listed above.&nbsp;WORK ENVIRONMENTWe’ll provide you training for, and ask you to maintain trained status for, and comply with, all relevant aspects of the PROCEPT BioRobotics Quality Management System to ensure product and support regulatory compliance. We would also ask you to understand and adhere to the PROCEPT BioRobotics Quality &amp; EHS policies.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Quality Engineer, Sustaining

<h3>Job Description</h3>
Job DescriptionCompany Description 
About Smiths Interconnect:
Smiths Interconnect,&nbsp;is a global leader in the design and manufacture of high-performance interconnect solutions. Our products are used in mission-critical applications across industries such as aerospace, defense, telecommunications, and industrial markets. At Smiths Interconnect, we are committed to innovation, quality, and providing cutting-edge solutions that connect the world’s most demanding systems.
Smiths Interconnect is part of Smiths Group. For over 170 years, Smiths has been pioneering progress by engineering for a better future. We serve millions of people every year, to help create a safer, more efficient and productive, and better-connected world across four global markets: energy, security &amp; defense, space &amp; aerospace and general industrial. Listed on the London Stock Exchange, Smiths employs c.16,000 colleagues in over 50 countries.&nbsp;
Job Description 
Job Purpose: 
Provides engineering expertise in assigned areas to ensure that all products are designed, procured, and built in accordance with customer and company quality requirements for sales growth and profitability.
Responsibilities: 
<ul>
<li>Support, contribute to and promote a safe work environment and Demonstrate behaviors consistent with company policies.</li>
<li>Investigate product-related problems and suggest solutions to the Engineering Manager or Director using industry-standard software to assess and optimize the thermal and mechanical performance of semiconductor components and systems while meeting other engineering requirements.</li>
<li>Design and develop new semiconductor products and redesign existing products to meet customer needs and specifications by creating detailed 3D models and engineering drawings ensuring accuracy and compliance with industry standards.</li>
<li>Design and develop revolutionary heat dissipation solutions, showcasing expertise in advanced heat sinks, liquid cold plate, thermal interfaces, and state-of-the-art cooling systems.</li>
<li>Perform, create, and update product design guidelines, customer standards, and analytical reports as assigned.</li>
<li>Participate in and contribute to team training, development, mentoring and audits.</li>
<li>Take charge of thermal management projects, providing strategic guidance, coordinating cross-functional teams, and ensuring successful project completion within aggressive timelines.</li>
<li>Evaluate and select appropriate materials for thermal management, considering factors such as thermal conductivity, heat dissipation, reliability etc. and conduct training sessions to share knowledge regarding materials and their application.</li>
<li>Conduct FEA (Finite Element Analysis) simulations to analyze, investigate potential failure modes and optimize the structural integrity of semiconductor components and systems thus providing insights to enhance designs for structural performance.</li>
<li>Collaborate with organizational stakeholders (Production, Quality, Marketing and Sales) and external customers to ensure the practicality and efficiency of designs for production.</li>
<li>Review drawings and documentation for compliance with project specifications and company policies and procedures.</li>
<li>Issues Engineering Change Release Notifications (ECN's) • Perform, create, and update product design guidelines, customer standards, and / or analytical reports as assigned.</li>
<li>Compliance and participation in all company EHS programs, policies, procedures, and training requirements</li>
</ul>
Up to 20% domestic travel may be required. 
Telecommuting permitted up to 20%. 
Qualifications 
Technical Knowledge, Skills, and Abilities:
Employer will accept a Bachelor's degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering or a related field and 5 years of progressive, post-baccalaureate experience in the job offered or in an Engineering III Materials-related occupation.
In the alternative, Employer will accept a Master’s degree (or foreign equivalent) in Mechanical Engineering, Biomedical Engineering or a related field and 6 months of experience in the job offered or in an Engineering III Materials-related occupation.
Position requires demonstrable experience in each of the following:
<ul>
<li>Utilizing the computer-aided engineering design software SolidWorks 3D;</li>
<li>Compliance with ASME GD&amp;T standards.</li>
<li>Utilizing Finite Element Analysis (structural, thermal and fluid);</li>
<li>Microsoft Office products including Word, Excel, and PowerPoint;</li>
<li>Knowledgeable in advanced materials and product design development activities including advanced process and manufacturing development technology;</li>
<li>Knowledge of plastics, molding, stampings, plating, cable assembly and terminations;</li>
<li>Knowledge of contact technologies and contact physics theory;</li>
<li>Performing Root Cause Analysis; and</li>
<li>Hands-on prototype development experience.</li>
</ul>
Position requires completion of a university-level course, research project, internship, or thesis, or work-related experience, with emphasis in thermal energy or heat transfer.
Up to 20% domestic travel may be required. 
Telecommuting permitted up to 20%. 
 Additional Information 
All your information will be kept confidential according to EEO guidelines.
We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.
At no time during the hiring process will Smiths Group, nor any of our recruitment partners ever request payment to enable participation – including, but not limited to, interviews or testing. Avoid fraudulent requests by applying jobs directly through our career’s website (Careers - Smiths Group plc)

Engineer III Materials

<h3>Job Description</h3>
Job Description
Job Title :&nbsp; Technical Solutions Engineer
Location : &nbsp;Hybrid 3x/week onsite in our San Bruno, CA&nbsp;94066 OR Dallas (Coppell), TX 75019
Duration : &nbsp;06 Months (Possible extension or conversion)

Job Description:

The Workbench Solutions Engineering team engages with all levels of the biomedical research community, from the data stewards who want to share data to the research investigators and their technical teams who want to put data to work. We provide insights and best practices for organizing and managing access to data and work with data scientists to help accelerate their research. The Workbench team is impacting major projects, including NIH AllOfUs and AMP PD.
Responsibilities:
<ul>
<li>Analyze a customer’s technical needs to provide recommendations for implementation and train customers and technical partners on how to use Workbench.</li>
<li>Work with customers to organize, harmonize, and securely share data on Google Cloud Platform and Amazon Web Services, and connect their internal data, tools, and processes to Workbench.</li>
<li>Build batch workflows and interactive analysis notebooks to process and analyze data at scale.</li>
<li>Improve product feature offerings by providing feedback to internal cross-functional teams including Product Management, User Experience, and Engineering.</li>
<li>Support Product and Sales teams, working directly with prospects and partners, to plan and implement both pilot and production projects.</li>
</ul>
Qualifications:

Minimum qualifications:
<ul>
<li>BA/BS degree in Computer Science or a related technical field or equivalent practical experience.</li>
<li>7+ years of experience working with one or more of the following programming languages: Python and/or Java, and the ability to write SQL queries of modest complexity.</li>
<li>Demonstrated creative problem-solving approach and strong analytical skills, combined with a strong sense of ownership, and a proactive can-do attitude.</li>
<li>Passion for using technology to advance biomedical insights and human health.</li>
<li>Excellent communication and project management skills, with a track record of handling multiple customers and streams of work.</li>
</ul>
Preferred qualifications:
<ul>
<li>Experience with public cloud services such as Google Cloud Platform, Amazon Web Services and/or Microsoft Azure.</li>
<li>Experience working with life science or biomedical research data, running batch workflows or analytical statistical analyses.</li>
<li>Experience installing common packaged software on Linux.</li>
<li>Experience building and deploying Docker images.</li>
</ul>
Company DescriptionWe believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list. 
<h3>Company Description</h3>
We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

Technical Solutions Engineer

<h3>Job Description</h3>
Job Description
The Process Development Engineer will lead the design and development of the digital processes for manufacturing patient-specific products processes. This role requires extensive collaboration with cross-functional teams, including Digital Production, Product Development, Digital Automation, Technology Development and Information Technology, to develop efficient and quality driven production processes. The ideal candidate will have a strong background in biomedical or mechanical engineering, a deep understanding of CAD systems, and a proven track record of process improvement in a regulated environment.
Duties and responsibilities
<ul>
<li>Leadership &amp; Collaboration: Serve as a key liaison between Digital Production and other departments, fostering strong relationships across the company and with external resources.</li>
<li>Goal Alignment: Understand the company’s objectives, responsibilities and mission, aligning work accordingly.</li>
<li>Planning and Adaptability: Prioritize and plan work activities to meet targets, adapting to changing conditions as needed.</li>
<li>Project Planning: Draft and maintain project plans to effectively communicate deliverables and targets.</li>
<li>Process Development: Design and implement scalable processes and systems for the creation of patient-specific products, ensuring compliance with FDA and ISO standards.</li>
<li>3D Modeling: Develop complex 3D models, drawings and reports using commercial, research and proprietary software for use within production processes.</li>
<li>Documentation: Draft detailed documentation to support process development projects and production processes.</li>
<li>Product Definition: Understand the product design specifications, goals and objectives to develop and refine Digital Production processes and systems.</li>
<li>Process Optimization: Evaluate and refine existing design procedures, implementing best practices to enhance workflow and reduce cycle times.</li>
<li>System Integration: Create/update Digital Production processes and systems that integrate into overall business processes and other manufacturing systems.</li>
<li>Software Projects: Participate in Digital Automation projects to develop/release new or updated software packages for use within the Digital Production systems.</li>
<li>Training: Train technical production staff, among others, fostering a culture of continuous learning and improvement.</li>
<li>Testing: Prepare, coordinate and execute various scopes of testing relative to projects.</li>
<li>Production Release: Prepare, coordinate and support production releases.</li>
<li>Problem Solving: Collaborate with Production, Product Development and Digital Automation teams, among others, to troubleshoot complex issues related to design and manufacturing processes.</li>
<li>Product Development: Participate in Product Development projects to innovate new processes and technologies that can enhance product offerings and operational efficiency.</li>
<li>Quality Assurance: Lead quality improvement initiatives and ensure adherence to quality management systems. Conduct regular audits and evaluations of existing processes to enhance accuracy and efficiency. Perform investigations and reporting as needed.</li>
<li>Other Duties: Perform all other duties or responsibilities as assigned.</li>
</ul>
Qualifications and experience
Required Skills: 
<ul>
<li>Excellent written and verbal communication skills.</li>
<li>Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.</li>
<li>Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.</li>
<li>Strong organizational, analytical, and time-management skills.</li>
<li>Self-motivated with the ability to work independently and collaboratively.</li>
<li>Interpersonal skills (verbal and written) sufficient for effective interaction with customers and colleagues.</li>
<li>Willingness to work flexible hours as needed.</li>
<li>Ability to adapt to changing conditions within the department, managing frequent interruptions.</li>
<li>Must demonstrate flexibility and willingness to adapt to diverse roles as a member of the corporate team.</li>
<li>Must be aware of hazards within the company; adhere to safety standards established by FDA and other regulatory agencies (large magnetic field, ionizing radiation, universal precautions, etc.).</li>
<li>Able to work in changing environments (reduced lighting, increased noise, temperature variances, unpleasant odors, etc.).</li>
<li>Willingness to learn needed skills on the job in order to enhance performance.</li>
<li>Understanding of various development, production and quality processes.</li>
<li>Be proactive and anticipate tasks required to complete assignments. </li>
</ul>
Education and Experience:
<ul>
<li>Minimum of 2-3 years’ experience using 3D CAD modeling software.</li>
<li>Experience with developing and implementing production processes.</li>
<li>Experience with software testing.</li>
<li>Experience in a regulated field, medical device field is a plus.</li>
<li>Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or equivalent Engineering</li>
</ul>
Physical Requirements: 
<ul>
<li>Prolonged periods sitting at a desk and working on a computer.</li>
</ul>

Process Engineer I

<h3>Job Description</h3>
Job DescriptionJob Title: Manufacturing Engineer Company: VistaApex Solutions Location: Racine, Wisconsin (Corporate Headquarters) Reports to: Director of Operations About VistaApex Solutions VistaApex Solutions is a purpose-driven, clinician-focused healthcare platform bringing together leading dental brands, including Vista Apex, PerioProtect, and PerioSciences. Our mission is to develop meaningful products that enhance clinicians’ treatment options and improve patient outcomes. With a value-added approach across R&amp;D, operations, and customer experience.&nbsp; We empower clinicians to deliver confident, consistent, and elevated care. At our core, we operate through five foundational pillars— Product Development + Clinician Involvement, Treatment Refinement + Simplified Workflow, Expanding Innovations + Trusted Partnerships, Inspired Foresight and Quality Assured + Personal Connections —guiding our approach to innovation, collaboration, and long-term partnership. Position Overview The Manufacturing Engineer plays a critical role in driving continuous improvement across VistaApex’s operations. This position is responsible for identifying and implementing opportunities to enhance product value, reduce costs, and improve overall performance through systematic analysis and sound engineering practices. A key responsibility of this role is to strengthen the vendor base for VistaApex. This includes identifying and onboarding new suppliers, either domestically within the United States or in international regions with favorable tariff structures. The Manufacturing Engineer will also support the integration and commissioning of new equipment at the VistaApex facility to support production and operational efficiency. This role collaborates closely with cross-functional teams, including design, sourcing, and supply chain, to ensure alignment of manufacturing initiatives with overall business objectives. Key Functions
<ul>
<li>Determines company product manufacturing needs and provides technical resources to accomplish a smooth transition within the manufacturing environment. Handling the handoff from project design to manufacturability and automating</li>
<li>Conduct thorough value analysis and engineering assessments on existing and new products to identify cost-saving opportunities and performance improvements.</li>
<li>Collaborate with design and manufacturing teams to implement effective design changes and material substitutions.</li>
<li>Lead workshops and brainstorming sessions to generate innovative ideas for product enhancements.</li>
<li>Analyze product lifecycle costs and provide recommendations to optimize value throughout the product development process.</li>
<li>Monitor and evaluate the effectiveness of implemented changes, providing feedback for continuous improvement.</li>
<li>Stay updated on industry trends and best practices in value engineering and product development.</li>
<li>Conduct comprehensive value analysis and engineering assessments on existing and new products to identify significant cost-saving opportunities and performance enhancements.</li>
<li>Lead the qualification and onboarding process for new vendors, ensuring alignment with company standards and strategic goals.</li>
<li>Solves problems associated with manufacturing fallout and system bottlenecks</li>
<li>Plans for the arrangement of machines within the plant facilities to ensure the most efficient production processing layout</li>
<li>Installation of automated equipment for tip manufacturing and kitting improvements</li>
<li>Plant Layout analysis while new business is onboarded</li>
<li>Open molds or identify new pieces of equipment to bring production of appropriate SKUs in house. Assist with the set-up of equipment and training personnel. </li>
<li>Identify and onboard new vendors in the United States and countries with lower tariffs to the United States to mitigate the current supply chain exposure.</li>
<li>Analyze dual source and dual path options for highest spend SKUs, to determine if it makes sense to bring production in house and to have multiple options in different countries.</li>
<li>Drive cost savings or cost avoidance initiatives for each SKU.</li>
<li>Push internal documentation through Vista Apex Change Control Process to qualify and approve new vendors.</li>
<li>Develop drawings, Receiving Inspection Reports, and other documentation needed for change management.</li>
<li>Other duties as assigned</li>
</ul>
The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required. Job Requirements
<ul>
<li>Bachelor’s degree in Engineering (Mechanical, Industrial, Biomedical, or related field) or equivalent experience; Master’s degree is a plus.</li>
<li>Proven experience in manufacturing engineering, preferably in a medical manufacturing environment.</li>
<li>Experience with product development and strong project management skills, including the ability to manage multiple projects simultaneously.</li>
<li>Proficient in Microsoft Office, particularly Excel; experience with Microsoft Project is helpful.</li>
<li>Proficient in engineering tools and software, such as CAD and other relevant technical applications.</li>
<li>Strong analytical and problem-solving skills, with a focus on cost reduction and performance improvement.</li>
<li>Excellent communication and interpersonal skills, with the ability to work collaboratively across teams.</li>
<li>Familiarity with lean manufacturing principles and continuous improvement methodologies is a plus.</li>
<li>Experience onboarding new vendors in previous roles is a plus.</li>
</ul>
Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>While performing the duties of this job, the employee is frequently required to sit; use hands to finger, handle, or touch objects; and talk or hear. The employee is occasionally required to stand, walk, climb or balance, and taste or smell. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and the ability to adjust focus.</li>
</ul>
Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
<ul>
<li>The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.</li>
<li>The position is an office-based position.</li>
<li>Fast-paced, dynamic environment requiring adaptability and proactive communication.</li>
</ul>
Benefits We believe in supporting our employees both inside and outside of work. Here’s what you can expect when you join our team:
<ul>
<li>Comprehensive Health Coverage: Medical, dental, and vision insurance for you and your dependents.</li>
<li>Time Off: Generous PTO policy and paid holidays</li>
<li>Retirement Plans: 401(k) with company matching to help you plan for the future.</li>
<li>Wellness Support: Mental health resources and wellness programs.</li>
<li>Team Connection: Regular team events, retreats, and gatherings to build community.</li>
</ul>
 &nbsp;
Powered by JazzHR
9BMSnhAIOw

Manufacturing Engineer

<h3>Job Description</h3>
Job DescriptionHumCap's client, a company in the biomedical technology space, is searching for a Manufacturing Engineer to join their team. This individual will help with the following&nbsp;duties
<ul>
<li>Plans, designs and analyzes manufacturing processes for devices and drug products.&nbsp;</li>
<li>Owns technical aspects of new-product-introduction activities to transfer designs robustly into manufacturing.&nbsp; </li>
<li>Determines equipment, tools, and processes needed to achieve manufacturing goals according to product specifications. </li>
<li>Maximizes efficiency by optimization of layout of equipment, workflow, assembly methods, and work force utilization.</li>
</ul>
RESPONSIBILITIES
<ul>
<li>Develop detailed layouts for equipment, manufacturing processes, and workflow.</li>
<li>Evaluate existing manufacturing processes to identify areas for improvements.</li>
<li>Research and develop new and/or improved processes, equipment, and products.</li>
<li>Design, purchase, install, characterize, and validate manufacturing equipment, fixtures, specialty assembly tools.</li>
<li>Develop, author, execute and document engineering investigations, process development studies, manufacturing work instructions, risk assessments, and validation protocols/reports (IQ, OQ, PQ).</li>
<li>Process owner for nonconformances and CAPAs that arise from manufacturing issues.</li>
<li>&nbsp;Own interactions with contract manufacturers and component suppliers for for issue resolution, component qualification, cost reduction and quality improvements.</li>
<li>Partner with Research to evaluate designs for manufacturability prior to production.</li>
<li>&nbsp;Preferred: Implement graphic arts designs and controlled content on finished product labels and packaging.</li>
</ul>
&nbsp;QUALIFICATIONSExperience and EducationExperience:·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Bachelor’s degree in engineering, preferably Mechanical Engineering, Electrical Engineering, Biomedical Engineering or related field required.&nbsp;·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minimum 5 years’ experience in medical devices, including a minimum of 3 years supporting active manufacturing operations under strict quality-system controls.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experience in contract manufacturing required.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experience with manual and semi-automated assembly processes for electromechanical devices required.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Familiar with processes for sterilization, bioburden, and endotoxin testing.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experienced with design transfer / new product introduction; has borne significant responsibilities in successful launch of at least one product, ideally orthopedic.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Experienced in requirements development, design-change analysis, risk management, and change-control procedures.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Understanding of GxP, FDA Quality System Regulations, ISO 13485, and ISO 14971.&nbsp;Skills and AbilitiesExcellent organizational and communication skills.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Ability to prioritize tasks and manage multiple projects effectively.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Demonstrates entrepreneurial spirit; able to thrive and contribute impactfully in an agile startup environment.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Hands-on, driven work ethic, with high attention to detail, and high ownership approach to process/product quality.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Ability to communicate complex technical data in format appropriate to support critical decision-making activities; excellent presentation skills and technical writing ability.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Solid grasp of statistical methods applicable to process development, investigations, and validation.·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Able to engage effectively with peers and project colleagues at contract manufacturing organizations, and with suppliers.&nbsp;Computer Software / ProgramsRequired proficiencies:·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Microsoft Office·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Google Suite·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SolidWorks or comparable CAD software·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Minitab or comparable statistics software &nbsp;Desired proficiencies:·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;SmartSheet project management software·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Python programming language·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Graphic-art software (e.g., Adobe Illustrator)·&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Commercial label-generation software (e.g., Bartender, Nicelabel, Labelview)

<h3>Job Description</h3>
Job DescriptionSenior Product Development Engineer&nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp; &nbsp;&nbsp; COMPANY OVERVIEW:Sage Product Development, Inc. provides fast, efficient and creative product development services to medical device companies.&nbsp; We are a focused team of experienced medical device engineers who know what it takes to develop successful products for startups, multinational companies, and everyone in between. We combine a high level of experience with a low overhead company structure. We solve client companies’ technical challenges and meet their product development needs in a timely, efficient and highly personalized manner. We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance their product development engineering abilities, and build their network within the industry. GENERAL SUMMARY:
<ul>
<li>Develop medical devices from concept through market introduction on a contract basis for client companies.</li>
<li>Meet or exceed customer expectations.</li>
</ul>
 ESSENTIAL JOB FUNCTIONS (all as required by client companies):
<ul>
<li>Manage product development projects. Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Proactively communicate task assignments to responsible individuals, and ensure that tasks are completed within the planned time. Track projects to project plans. Proactively report project status to Sage personnel and to the project’s client company.</li>
<li>Generate project timing and expense estimates and prepare project proposals for client companies.</li>
<li>Design and develop medical devices (disposable and reusable), catheters, equipment, implants, and/or packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements.</li>
<li>Interact with client companies in a professional manner. Proactively communicate with client companies to ensure an ongoing two-way exchange of information.</li>
<li>Generate innovative concepts for new medical device designs to satisfy customer and clinical requirements. Lead and participate in concept generation activities, including brainstorming sessions. Refine, rate, rank and/or otherwise assess concepts.</li>
<li>Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component, subassembly, and top-level drawings.</li>
<li>Investigate and evaluate existing technology for application to projects.</li>
<li>Design and implement new methodologies, materials, machines, processes or products as required to achieve product development goals.</li>
<li>Produce prototype devices for testing and evaluation. Work with internal and/or external resources to produce prototype device components. Assemble and/or evaluate prototype devices.</li>
<li>Conduct bench and/or animal feasibility studies.</li>
<li>Conduct product verification and validation testing to demonstrate product safety and efficacy. Determine what testing is required to satisfy product requirements, to investigate potential failure modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test results. Write test reports which draw conclusions from the results.</li>
<li>Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.</li>
<li>Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.</li>
<li>Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet customer expectations.</li>
<li>Maintain detailed essential product and process documentation throughout all phases of research and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete and well organized.</li>
<li>Prepare documentation release packages, including detail drawings, bills of material, and/or procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as required.</li>
<li>Ensure that all work satisfies the requirements of client companies’ Quality Systems, with particular emphasis on Design Control.</li>
<li>Conduct and document Design Reviews.</li>
<li>Participate in Material Review Board activities. Make decisions regarding product and material discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.</li>
<li>Date, sign and have witnessed all documents that may establish inventorship dates.</li>
<li>Some local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).</li>
</ul>
OTHER DUTIES AND RESPONSIBILITIES:
<ul>
<li>Any other duties as assigned.</li>
</ul>
REQUIRED COMPETENCIES:Customer Focus
<ul>
<li>Provide professional, reliable and prompt service to client companies and coworkers. Work in partnership with others to meet or exceed customer expectations. Interpret customers’ needs and take appropriate action. Follow through on customers’ inquiries in a professional and timely manner.</li>
</ul>
Management of Resources
<ul>
<li>Work in an organized and time effective manner. Proactively seek out relevant reference materials as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative and innovation in the use of available resources.</li>
</ul>
Communication Skills
<ul>
<li>Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong verbal presentation and negotiation skills. Interact with client company personnel in a positive and professional manner. Express ideas, recommendations and solutions clearly, logically and concisely in both written and verbal communications. Demonstrate tact and diplomacy in communications. Demonstrate active listening skills and ability to resolve discrepancies with customers.</li>
</ul>
PREPARATION, KNOWLEDGE, SKILLS &amp; ABILITIES:
<ul>
<li>Bachelor's degree in Mechanical, Biomedical or Electromechanical Engineering is required. Master’s degree in engineering, management or business is a plus.</li>
<li>Project management experience is required.</li>
<li>Some prior medical device product design and development experience is required.</li>
<li>Demonstrated ability to bring products from concept to market.</li>
<li>Ability to interact with client companies in a professional manner.</li>
<li>SolidWorks 3D CAD proficiency is required.</li>
<li>Knowledge of probability and statistics.</li>
<li>Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.</li>
<li>Familiarity with FDA QSR and ISO 13,485 medical device regulations.</li>
<li>Depth of knowledge in one or more clinical areas.</li>
<li>Depth of knowledge in one or more medical device product areas.</li>
<li>Depth of knowledge in one or more technical areas, for example finite element analysis.</li>
</ul>
BONUS:
<ul>
<li>Experience in development of catheter-based devices.</li>
<li>Experience in electrical and/or electromechanical medical device design and development.</li>
</ul>
SUPERVISORY RESPONSIBILITY:
<ul>
<li>May direct the work of other people, and may have direct reports.</li>
</ul>
REPORTS TO: Engineering Manager&nbsp; &nbsp; WORKING CONDITIONS/PHYSICAL DEMANDS:
<ul>
<li>Must be able to move throughout office and laboratory space, using a complete variety of office equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand for extended periods of time. Must tolerate exposure to chemicals found in a laboratory environment.</li>
<li>The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.</li>
<li>External and internal applicants, as well as position incumbents who become disabled as defined under the Americans with Disabilities Act must be able to perform the essential job functions (as listed) either unaided or with the assistance of a reasonable accommodation to be determined by management on a case by case basis.</li>
</ul>

894 biomedical engineer Jobs