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<h3>Job Description</h3>
Job DescriptionJob Title: Project Engineer Company: VistaApex Solutions Location: Racine, WI | Hybrid 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 This position provides engineering and technical support to the Quality, Engineering, and Operations/Production departments. The role is responsible for assisting with a variety of initiatives and projects, including New Product Development (NPD), cost reduction, process and operational efficiency improvements, Change Control, NCR/CAPA investigations, new market development, and risk management activities. Key Functions
<ul>
<li>Design and Development
<ul>
<li>Produce and implement product and process designs that meet performance, quality, and regulatory requirements.</li>
<li>Design, develop, test, and modify products, components, equipment, and devices to support new and existing product lines.</li>
<li>Create test procedures, fixtures, and protocols to support product characterization, experimentation, validation, and production activities.</li>
<li>Undertake relevant research and apply engineering principles to support innovation and continuous improvement.</li>
</ul>
</li>
<li>Testing, Analysis, and Documentation
<ul>
<li>Analyze and interpret engineering and test data to support product performance evaluation and decision-making.</li>
<li>Develop and document procedures for sub-assembly and final product inspection and testing.</li>
<li>Implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.</li>
<li>Conduct first-article inspections and establish appropriate incoming inspection methods and criteria.</li>
<li>Design or specify inspection and testing mechanisms and equipment; perform statistical analysis to assess nonconformance and determine root cause and corrective actions.</li>
<li>Draft and maintain quality assurance documentation and technical reports, including Corrective and Preventive Actions (CAPAs), Non-Conformance Reports (NCRs), complaint trending and analysis, and Clinical Evaluation Reports (CERs).</li>
<li>Ensure all documentation and reporting follow Good Documentation Practices (GDP) and company quality policies.</li>
</ul>
</li>
<li>Manufacturing and Equipment Support
<ul>
<li>Support device manufacturing and production by troubleshooting, improving, and maintaining processes and equipment.</li>
<li>Maintain and implement new manufacturing-related equipment to enhance production efficiency and quality.</li>
<li>Maintain calibration and preventive maintenance schedules for production tools and equipment to ensure accuracy and reliability.</li>
</ul>
</li>
<li>Quality, Collaboration, and Compliance
<ul>
<li>Collaborate closely with Engineering, Quality, and Manufacturing functions to ensure quality standards and compliance requirements are met.</li>
<li>Assure proper documentation and traceability of all technical data generated for assigned projects in alignment with engineering policies and procedures.</li>
<li>Contribute to quality system improvements and initiatives that drive consistency, reliability, and regulatory compliance.</li>
<li>May specialize in areas such as design, incoming material inspection, production control, product evaluation and reliability, inventory control, or research and development as they relate to product and process quality.</li>
</ul>
</li>
<li>Additional Duties
<ul>
<li>Perform other related duties as assigned to support departmental and organizational objectives.</li>
</ul>
</li>
</ul>
Qualifications
<ul>
<li>Education
<ul>
<li>Bachelor’s Degree in Engineering (Mechanical, Biomedical, Chemical, or related discipline preferred).</li>
<li>Additional coursework or training in chemistry, materials science, manufacturing, or quality systems is a plus.</li>
</ul>
</li>
<li>Experience
<ul>
<li>Previous research, co-op, internship, or industry experience in an engineering or manufacturing environment required; preference for experience in the medical device industry or other regulated manufacturing setting.</li>
<li>Familiarity with ISO 13485, MDSAP, and MDD quality management systems and regulatory frameworks preferred.</li>
<li>Experience working in or supporting laboratory or production environments, including wet lab techniques (e.g., titrations, dilutions, sample preparation).</li>
<li>Knowledge of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and general lab safety procedures.</li>
</ul>
</li>
<li>Skills and Competencies
<ul>
<li>Strong communication skills, including the ability to clearly convey technical information in written reports, verbal discussions, and electronic correspondence.</li>
<li>Ability to communicate effectively with both internal team members and external partners, including through telephone, email, and in-person meetings.</li>
<li>Comfortable making formal presentations to small or large groups, including cross-functional teams or leadership.</li>
<li>Proven problem-solving and analytical skills, with the ability to identify issues, evaluate options, and implement practical solutions.</li>
<li>Proficiency in standard software applications, including Microsoft Word, Excel, PowerPoint, and other data analysis or documentation tools.</li>
<li>Ability to work independently and collaboratively, manage multiple priorities, and maintain accuracy and attention to detail in a fast-paced environment.</li>
</ul>
</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>Regularly required to sit, stand, and walk for extended periods.</li>
<li>Must be able to lift, carry, and move materials or equipment up to approximately 25 pounds.</li>
<li>Occasional bending, stooping, or reaching may be required when working with equipment or materials.</li>
<li>Frequent use of hands, fingers, and fine motor skills to operate computers, tools, instruments, and test equipment.</li>
<li>Visual acuity required for reading technical documents, operating equipment, and performing detailed inspection or testing tasks.</li>
<li>May require the use of personal protective equipment (PPE) such as safety glasses, gloves, or lab coats when working in lab or production areas.</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>Hybrid work schedule with a mix of office-based and on-site/laboratory/manufacturing floor activities.</li>
<li>Office environment includes standard computer and communication equipment.</li>
<li>On-site work may involve exposure to manufacturing equipment, chemicals, and controlled environments where safety and cleanliness protocols must be followed.</li>
<li>Work may occasionally require flexibility in hours to support production schedules, testing, or project deadlines.</li>
<li>Collaboration with cross-functional teams in both in-person and virtual settings.</li>
<li>The role requires adherence to all environmental, health, and safety (EHS) standards and company policies.</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;
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r7XRYlwmhy

Project Engineer

<h3>Job Description</h3>
About Expanding Innovations
 
At Expanding Innovations, Inc. (EI), we’re redefining what’s possible in spinal fusion. As a fast-growing leader in non-screw-based expandable cage technologies, we’re committed to solving the most complex clinical challenges faced by today’s spine surgeons—ultimately improving patient outcomes through innovation.
 
We’re looking for a driven and experienced R&amp;D Engineer to join our collaborative, fast-paced team and help shape the future of spinal device technology.

 
Position Overview
 
This on-site role is ideal for an engineer who thrives on innovation, cross-functional collaboration, and seeing ideas through from concept to commercialization. You’ll lead one or more product development projects while contributing to a broader portfolio of initiatives across the R&amp;D team.

 
Key Responsibilities
 
Project Leadership
<ul>
<li>Lead one or more product development projects from concept through launch.</li>
<li>Collaborate with cross-functional teams (Product Management, Regulatory, Quality, Manufacturing) to meet project milestones on time and within budget.</li>
<li>Maintain clear project plans and Design History Files (DHF) in compliance with FDA and ISO 13485 standards.</li>
</ul>
 
Design &amp; Development
<ul>
<li>Drive the technical design process, including prototyping, testing, and validation.</li>
<li>Apply engineering principles to optimize product performance, usability, and manufacturability.</li>
<li>Conduct geometric tolerancing analysis and design optimization to enhance the end-user experience.</li>
<li>Participate in and lead product testing (feasibility, ASTM, validation, etc.).</li>
</ul>
 
Risk &amp; Compliance
<ul>
<li>Develop and manage risk documentation (DFMEA, PFMEA, UFMEA) in collaboration with the team.</li>
<li>Ensure adherence to design controls and regulatory requirements throughout the development lifecycle.</li>
</ul>
 
Innovation &amp; IP
<ul>
<li>Contribute to a culture of innovation by generating new ideas, patents, and intellectual property.</li>
<li>Stay current on industry trends, competitive technologies, and emerging materials.</li>
</ul>
 

Qualifications
 
Required:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field (Master’s or Ph.D. preferred).</li>
<li>5+ years of mechanical design experience in the medical device industry.</li>
<li>Proven track record of leading complex product development projects.</li>
<li>Deep understanding of spinal anatomy, biomechanics, and surgical techniques.</li>
<li>Proficiency in CAD (e.g., SolidWorks), FEA, and other engineering tools.</li>
<li>Strong knowledge of FDA regulations, ISO 13485, and ASTM testing standards.</li>
<li>Excellent communication skills—able to convey complex technical concepts to diverse audiences.</li>
<li>Strong interpersonal skills and a collaborative mindset.</li>
<li>Authorized to work in the U.S. (Visa sponsorship is not available for this role).</li>
</ul>
 
Preferred:
<ul>
<li>A strong preference for work experience in the spine surgical device space, most notably interbody fusion procedures.</li>
<li>Experience with expandable interbody fusion devices.</li>
<li>Expertise in GD&amp;T, 1D tolerance analysis, and 3D modeling/analysis.</li>
<li>Familiarity with sterile packaging and cleanroom manufacturing.</li>
<li>Knowledge of cost-of-goods (COG) optimization through design for manufacturability.</li>
<li>Hands-on experience with manufacturing methods such as machining, injection molding, sheet metal forming, and thermoforming.</li>
</ul>
 
Salary Range: Expanding Innovations, Inc. (EI) complies with all state and federal wage and hour laws.&nbsp;Exact compensation may vary&nbsp;based on candidate’s qualifications, experience, and exact location. $110,000 to $145,000 Full-Time Annual Salary, with annual bonus opportunities and stock incentives.&nbsp;&nbsp;
 
Why Join Us?
<ul>
<li>Be part of a mission-driven team transforming spinal surgery.</li>
<li>Work on cutting-edge technologies with real clinical impact.</li>
<li>Grow your career in a dynamic, innovation-focused environment.</li>
</ul>

R&D Engineer

<h3>Job Description</h3>
Position Summary:
The Process Engineer will take ownership of manufacturing and packaging process leadership—evaluating current systems, identifying areas for improvement, and driving initiatives that enhance efficiency, quality, and compliance. This role requires a self-starter with strong process validation experience, a continuous improvement mindset, and the confidence to lead cross-functional initiatives in a regulated medical device environment.
 
Key Responsibilities:
<ul>
<li>Lead process improvement efforts across manufacturing and packaging operations to optimize quality, performance, and throughput.</li>
<li>Assess current processes, identify root causes of inefficiencies, and implement data-driven solutions.</li>
<li>Plan, execute, and document IQ/OQ/PQ validations in compliance with FDA and ISO 13485 requirements.</li>
<li>Partner with Regulatory and Quality teams to evaluate process changes and ensure full regulatory compliance.</li>
<li>Provide engineering support for process changes related to new product introductions, packaging redesign, and manufacturing transfers.</li>
<li>Use CAD tools to support packaging redesigns, equipment layouts, and process documentation.</li>
<li>Lead cross-functional teams in implementing continuous improvement and lean manufacturing initiatives.</li>
<li>Prepare and maintain technical documentation, including protocols, reports, and risk analyses.</li>
</ul>
 
Qualifications:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.</li>
<li>5+ years of experience in process engineering within a medical device (Class III preferred) or similarly regulated manufacturing environment.</li>
<li>Proven experience with IQ/OQ/PQ validations and process documentation.</li>
<li>Strong understanding of FDA regulations, ISO 13485, and GMP principles.</li>
<li>Demonstrated success leading continuous improvement or lean manufacturing projects.</li>
<li>Excellent analytical, communication, and project management skills.</li>
<li>CAD proficiency (SolidWorks or equivalent) preferred.</li>
<li>Must be self-motivated, proactive, and capable of driving initiatives independently.</li>
</ul>

Process Engineer

<h3>Job Description</h3>
Lumira Search is recruiting an R&amp;D Engineer for a Class III cardiovascular device manufacturer in Minneapolis. We’re looking for a hands-on R&amp;D Engineer to help design, prototype, and test innovative devices used in interventional cardiology.
 
Tasks
<ul>
<li>Develop and optimize Class III cardiovascular devices</li>
<li>Collaborate across R&amp;D, quality, and manufacturing teams</li>
<li>Conduct testing, analysis, and design improvements</li>
<li>Document processes in compliance with regulatory standards</li>
</ul>
 
Requirements
<ul>
<li>B.S./M.S. in Biomedical, Mechanical, or related Engineering</li>
<li>2+ years in medical device R&amp;D (Class III cardiological devices)</li>
<li>Experience with CAD, testing, and regulatory standards</li>
<li>Strong problem-solving and teamwork skills</li>
</ul>
 
Why join
<ul>
<li>Work on life-saving technology</li>
<li>Collaborative, innovative environment</li>
<li>Career growth opportunities</li>
</ul>
 
To apply, please email <a href="mailto:jchristopher@lumirasearch.com" target="_blank">jchristopher@lumirasearch.com</a> with a copy of your resume. If you do not have experience with class III cardiology devices you will not be considered for the role.
 
Please note: I expect a high volume of applicants and I'm simply unable to respond to all, if you do not meet the above criteria and haven't heard back within 14 days of applying, please assume your application is unsuccessful.

<h3>Job Description</h3>
Job DescriptionDEKA Research and Development, housed in Manchester, NH, is looking for a Jr. Mechanical Engineer to participate in the development of innovative medical devices. They will work as part of a team driving products through their lifecycle including concept generation, prototyping, component and assembly development, testing, and associated documentation.&nbsp; How you will make an impact as a Junior Mechanical Engineer:
<ul>
<li>Generate creative solutions to design problems and demonstrate their viability considering factors such as risk, reliability, manufacturability, serviceability, weight and cost</li>
<li>Transition concepts into products using 3D CAD Solid Modeling, defining requirements, selecting materials and&nbsp;processes, interacting with suppliers and manufacturers, and documenting the development process</li>
<li>Troubleshoot design failure modes to root cause and develop quick, effective solutions</li>
<li>Coordinate with others in a multi-disciplinary team environment including test, manufacturing, systems, biomedical, and electrical</li>
<li>Develop assembly fixtures, nests, and jigs – designing components, conducting process development and design of experiment (DOE), and selecting components</li>
<li>Evaluate designs through prototype testing and requirement verification</li>
<li>Set an excellent example of mechanical engineering practices and provide a level of mentorship to less knowledgeable engineers.</li>
</ul>
To be successful in this role, you will need the following skills and experience:
<ul>
<li>BS, Mechanical Engineering Degree</li>
<li>1+ years’ experience designing electromechanical products, internship experience considered</li>
<li>Demonstrated experience designing parts using a variety of manufacturing methods, ie: machining, welding, injection molding, forming, forging, casting</li>
<li>Proficient user of Solidworks or other comparable CAD software</li>
<li>Must have experience producing engineering drawings and fundamental GD&amp;T knowledge</li>
<li>Must have experience with finite element analysis and tolerance analysis</li>
<li>Must be able to work in an open group environment</li>
<li>Experience designing medical equipment is a plus</li>
<li>Surfacing experience a plus</li>
<li>Experience designing dynamic systems with electro-mechanical devices is a plus</li>
</ul>
About DEKA: One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research &amp; Development, where we are taking the same innovation and cutting-edge technology into the modern age. Behind DEKA’s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored. &nbsp;
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Qs5CaDlE6q

Junior 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. As PROCEPT BioRobotics continues to expand, the Design Quality Assurance group is seeking a Reliability Quality Engineer to support ongoing reliability initiatives. The Reliability Quality Engineer will collaborate with product development and sustaining teams to ensure that PROCEPT BioRobotics delivers highly reliable products through the application of reliability tools such as Weibull Analysis, Failure Mode Effects &amp; Criticality Analysis (FMECA), Fault Tree Analysis (FTA), structured problem-solving, reliability modeling, reliability predictions, and reliability testing.What Your Day-To-Day Will Involve:
<ul>
<li>Define and execute reliability testing protocols for mechanical, electrical, environmental, and software-related systems.</li>
<li>Support Design Control activities, risk management files, verification and validation protocols, and design reviews.</li>
<li>Collaborate with cross-functional teams (R&amp;D, Manufacturing, Supplier Quality, Regulatory, and Failure Analysis) to ensure product quality, reliability, and compliance.</li>
<li>Monitor field reliability metrics, complaint data, and nonconformance trends.</li>
<li>Understand and adhere to the PROCEPT BioRobotics EHS policy.</li>
</ul>
The Qualifications We Need You to Possess
<ul>
<li>Evaluate and demonstrate the reliability of mechanical, electrical, and electronic components within complex medical robotic systems.</li>
<li>Perform reliability prediction analyses using established industry standards such as MIL-HDBK-217, Telcordia, and FIDES.</li>
<li>Apply knowledge of ISO 13485 and 21 CFR Part 820, and remain familiar with other applicable international standards.</li>
<li>Define reliability requirements and develop new test specifications, methodologies, and coverage strategies to ensure the reliability of both current and next-generation products.</li>
<li>Plan and conduct Accelerated Life Testing (ALT) and Highly Accelerated Life Testing (HALT) to assess product design robustness.</li>
<li>Design and build custom test fixtures and automated setups for reliability testing at the system, subsystem, and component levels.</li>
<li>Maintain automated testing frameworks using Python and C++ for test execution and data analysis.</li>
<li>Demonstrate strong attention to detail, excellent organization, and effective communication skills, with flexibility and adaptability to take on new tasks.</li>
</ul>
The Qualifications We Would Like You to Possess
<ul>
<li>Bachelor’s degree with 2 years of relevant experience, or Master’s degree with 1 year of relevant experience in Mechanical, Biomedical, or Electrical/Electronic Engineering.</li>
<li>Ability to learn and apply statistical processes and techniques such as prediction and Weibull analysis.</li>
<li>Strong written and verbal communication skills.</li>
<li>ASQ CQE or CRE certification preferred.</li>
<li>Basic machine tool and manufacturing experience is a plus.</li>
<li>Experience with medical device testing or product development is a plus.</li>
</ul>
For US-Based Candidates OnlyWork Authorization Status: Citizen / Permanent Resident&nbsp;For this role, the anticipated base pay range is $100,000-118,000 per year.Plus, eligibility for an annual bonus and equity/RSUs Understanding 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.

Reliability Quality Engineer

<h3>Job Description</h3>
Job DescriptionBridgeMed Solutions, Inc is seeking a Manufacturing Engineer. Training will be provided. &nbsp; &nbsp; Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives. &nbsp; Job Title: Manufacturing Engineer Experience: +3 years of experience in Engineering, experience in medical device is a plus.&nbsp; Location: Local candidates only (must live in Orange County) Job Type: Full Time, 100% In-House Salary: $33-$43 DOE (Non-Exempt) Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage,&nbsp; Principal Duties and Responsibilities 
<ul>
<li>Experience in medical device manufacturing. - Suture or Catheter Experience is a PLUS!</li>
<li>Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).</li>
<li>Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.</li>
<li>Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.</li>
<li>Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.</li>
<li>Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.</li>
<li>Project and client management is a must&nbsp;</li>
</ul>
Skills and Qualifications 
<ul>
<li>Bachelor's or Master's degree in Engineering Preferred (Biomedical, Mechanical, or related field).</li>
<li>Minimum of 3 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.</li>
<li>Proven experience in project management and cross-functional team collaboration.</li>
<li>Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.</li>
<li>Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.</li>
<li>Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab) is a plus.</li>
<li>Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.</li>
</ul>

Engineer (Medical Device)

<h3>Job Description</h3>
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Beckman Coulter Life Sciences, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.
You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.
At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today: time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.
We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.
It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow.
Learn about the Danaher Business System which makes everything possible.
The Senior Mechanical Engineer is responsible for Designing and developing mechanical systems for instruments used in medical research. This role drives product development from concept through production and supports existing products to meet safety, reliability, and customer expectations..
This position reports to the Development Engineering Manager and is part of the Centrifuge team located in Indianapolis, IN and will be an on-site role.&nbsp;
In this role, you will have the opportunity to:
<ul>
<li>Lead product development of modules and collaborate across engineering disciplines.</li>
<li>Design and analyze mechanical systems to meet product specifications.</li>
<li>Develop and execute component and system tests for performance validation.</li>
<li>Participate in design reviews and ensure adherence to quality system requirements.</li>
<li>Maintain and improve existing products for safety and reliability.</li>
</ul>
The essential requirements of the job include:
<ul>
<li>B.S. in Mechanical Engineering or Biomedical Engineering with 5+ years of experience designing and developing products.</li>
<li>Strong proficiency in SolidWorks CAD, GD&amp;T, and documentation of design.</li>
<li>Excellent analytical and problem-solving skills including tolerance analysis, FEA, and Thermodynamics.</li>
</ul>
It would be a plus if you also possess previous experience in:
<ul>
<li>A solid foundation of hands on tooling as well as hands-on machining and rapid 3D prototyping.</li>
<li>ISO quality systems related to design control and product release.</li>
<li>Mechanical assemblies and systems design of medical laboratory instrumentation.</li>
<li>SolidWorks modeling of machined, sheet metal, and injection molded parts.</li>
<li>Strong understanding of current manufacturing processes for low volume, high mix products</li>
<li>Print creation using ASME dimensioning and tolerance standards.</li>
<li>Materials selection for reliability and chemical compatibility.</li>
</ul>
Beckman Coulter Life Sciences, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. 
For more information, visit <a href="http://www.danaher.com" target="_blank">www.danaher.com</a>. 
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Senior Mechanical Engineer

<h3>Job Description</h3>
Job Description
Position Summary:
We are seeking a detail-oriented and hands-on Secondary Operations Engineer / Process Engineer to join our medical tubing manufacturing team. This role is responsible for the development, validation, and continuous improvement of secondary operations processes to ensure high-quality, cost-effective production of medical-grade tubing products. The ideal candidate will bring strong technical skills, process engineering experience, and a deep understanding of quality standards within a regulated manufacturing environment.
Key Responsibilities:
<ul>
<li>Develop, implement, and optimize secondary operations for medical tubing, including cutting, hole punching, tipping, flaring, bonding, printing, molding and assembly.</li>
<li>Design and validate fixtures, tools, and equipment to support post-extrusion processes.</li>
<li>Collaborate with suppliers and equipment vendors for tooling design, maintenance, and upgrades.</li>
<li>Create, implement and maintain process documentation (work instructions, process flows, validation protocols, etc.).</li>
<li>Work with cross-functional teams (R&amp;D, Quality, Production) to support new product introductions and process scale-up.</li>
<li>Collaborate with Sales on evaluating and quoting new products, new product development and customer support. Participate in weekly review meetings to align capabilities with customer specifications.</li>
<li>Work with quality to conduct root cause analysis and lead corrective/preventive actions (CAPA) for process issues or non-conformances.</li>
<li>Train and support operators on new or revised secondary processes.</li>
<li>Follow and maintain a schedule of active projects and give necessary updates.</li>
<li>Drive continuous improvement and cost reduction initiatives using lean manufacturing and Six Sigma principles.</li>
<li>Facilitate project scale up activities including transferring manufacturing across multiple locations.</li>
</ul>
Qualifications:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related field.</li>
<li>5+ years of experience in medical device manufacturing or plastic tubing industry.</li>
<li>Hands-on experience with secondary operations processes and automation.</li>
<li>Familiarity with GMP, ISO 13485, and FDA regulations.</li>
<li>Strong troubleshooting skills and knowledge of statistical process control.</li>
<li>Experience with validation (IQ/OQ/PQ) and process documentation.</li>
<li>Excellent communication, documentation and project management skills.</li>
</ul>
Preferred Skills:
<ul>
<li>Experience with laser cutting, RF welding, or thermal bonding.</li>
<li>Proficient in CAD software (SolidWorks or similar) and Microsoft Office Suite.</li>
<li>Knowledge of polymer materials commonly used in medical devices (e.g., PVC, Pebax, Polyurethane).</li>
<li>Lean Six Sigma certification (Green Belt or higher).</li>
<li>Bilingual in Spanish, a plus</li>
<li>Prior Secondary Operations experience on molded or manufactured parts</li>
</ul>
Proterial Cable America, Inc. is a second chance employer. We believe in giving individuals who have made past mistakes an opportunity to rebuild their lives and contribute positively to society. People with criminal records are encouraged to apply.

Secondary Ops Engineer / Process Engineer

<h3>Job Description</h3>
Job Description
Job Summary: The Quality Engineer will be responsible for assisting in the development, implementation, and maintenance of the quality system of the company including supporting all FDA and registrar inspections/audits. Candidates must be located within commuting distance to the Wilmington, MA or willing to relocate to be considered. Essential Duties and Responsibilities:
<ul>
<li>Contributes to design and process verification and validation activities including definition and qualification of test methods, acceptance criteria, and statistical principles. Assists in writing and reviewing protocols, reports, and operating procedures to support product and process development.</li>
<li>Supervises and performs risk management activities including creation and maintenance of risk management files by product and process as the key quality representative for those tasks.</li>
<li>Support design control new product introduction teams as the quality subject matter expert and provide review and approval of product Design History Files.</li>
<li>Act as the leader in bringing the culture of quality in medical device development.</li>
<li>Exercise independent judgment in evaluating complex processes, procedures and systems against written regulatory requirements and company procedures.</li>
<li>Collaborate with and guide cross-functional team members and stakeholders to ensure correct and efficient implementation of Design Controls and Quality System procedures.</li>
<li>Active participant in assigned Design and Phase Review meetings.</li>
<li>Drives improvements to the QMS including those resulting from quality events, audits, or regulatory changes to ensure compliance with FDA 21 CFR 820.</li>
<li>Assisting in the development of the company quality system to support medical device offerings and operations and ensure continual improvement in quality. This may include drafting and reviewing quality system documents as necessary, managing document change requests, and regularly reviewing procedures for appropriateness.</li>
<li>Assisting with quality system implementation including, but not limited to:
<ul>
<li>Maintaining and documenting supplier approvals and audits as needed.</li>
<li>Participating in internal audits and serving as subject matter expert during regulatory inspections and notified body audits.</li>
<li>Assisting with and documenting regular management reviews.</li>
<li>Drafting and executing IQs, OQs, and PQs, where applicable.</li>
<li>Initiating, investigating, and reviewing non-conformances as well as corrective and preventative actions, as assigned.</li>
<li>Assisting in product failure and root cause investigations.</li>
</ul>
</li>
<li>Generally assuring adherence to all company quality procedures</li>
<li>Other responsibilities as assigned.</li>
</ul>
 Qualifications:
<ul>
<li>Bachelor’s degree in mechanical engineering or biomedical engineering.</li>
<li>Six Sigma Certification – Green, Brown or Black belt preferred.</li>
<li>ASQ CQE preferred.</li>
</ul>
 Skills, Abilities, Competencies Required:
<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>Able to self-motivate and work both independently and as part of a team.</li>
</ul>

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