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<h3>Job Description</h3>
Job DescriptionSENIOR MECHANICAL ENGINEER
Freeform is deploying software-defined, autonomous metal 3D printing factories around the world, bringing the scalability of software to physical production. Our proprietary technology stack leverages advanced sensing, real-time controls, and data-driven learning to produce digitally-verified, flawless parts at unprecedented speed and cost. Our mission is to make the transformative power of 3D printing available to all industries at scale and unlock the future of innovation. 
As a Senior Mechanical Engineer at Freeform, you will be responsible for leading mechanical design efforts across the company, as well as for driving the pace of innovation and maximizing hardware development speed. To be successful in this role, you must have extensive technical breadth in mechanical engineering concepts as well as specific expertise in architecting, designing, and developing complex mechanical systems, advanced robotics systems, or state-of-the-art industrial automation systems. The ideal candidate is capable of acting as the technical lead for a complex system with the ability work across engineering disciplines.
3D printing experience is not required to be successful here - rather we look for smart, motivated, collaborative engineers who love solving hard problems and creating amazing technology! 
Responsibilities:
<ul>
<li>Act as a responsible engineer in bringing hardware from concept to production</li>
<li>Research, develop, design, and test complex mechanical components, subassemblies, equipment, and systems</li>
<li>Perform tolerance analysis of designs at the system and subsystem level</li>
<li>Plan and perform tests to analyze the feasibility, design, operation and performance of equipment, components, and systems</li>
<li>Work hands-on to build, integrate, and validate designs and newly developed systems and/or subsystems</li>
<li>Strategize continuous improvement plans to enhance system performance, reliability, and manufacturability</li>
</ul>
Basic Qualifications:
<ul>
<li>Bachelor's degree in mechanical engineering or related technical field</li>
<li>5+ years of experience in mechanical systems design and development</li>
<li>CAD experience, including GD&amp;T and detailed drawing documentation</li>
<li>Strong mechanical engineering fundamentals with extensive hands-on hardware development experience</li>
<li>Systems-level thinker also able to perform detailed work; has previously delivered complex mechanical systems</li>
</ul>
Nice to Have:
<ul>
<li>10+ years of experience designing mechanical systems for semiconductor, machining, automation, materials processing, or other related industrial manufacturing or capital equipment applications (e.g. additive manufacturing, semiconductor, robotics, CNC, or biomedical manufacturing equipment design engineering experience)</li>
<li>Advanced degree in mechanical engineering</li>
<li>Knowledge of motion control and kinematics</li>
<li>Experience with design of fluid or thermal systems</li>
<li>Working knowledge of electromechanical systems</li>
<li>Passion for improving the state of metal 3D printing</li>
<li>Excellent verbal and written communication skills</li>
</ul>
Location:
<ul>
<li>We are located in Hawthorne, CA in a 35,000 square foot, state-of-the-art facility featuring large open spaces for team collaboration, R&amp;D, and production, as well as easy access to the 405, 105, and 110 freeways. Our facility is in the heart of Los Angeles' vibrant emerging tech ecosystem alongside many other high growth startups and enterprises.</li>
</ul>
What We Offer:
<ul>
<li>We have an inclusive and diverse culture that values collaboration, learning, and making deliberate data-driven decisions.</li>
<li>We offer a unique opportunity to be an early and integral member of a rapidly growing company that is scaling a world-changing technology.</li>
<li>Benefits
<ul>
<li>Significant stock option packages</li>
<li>100% employer-paid Medical, Dental, and Vision insurance (premium PPO and HMO options)</li>
<li>Life insurance</li>
<li>Traditional and Roth 401(k)</li>
<li>Relocation assistance provided</li>
<li>Paid vacation, sick leave, and company holidays</li>
<li>Generous Paid Parental Leave and extended transition back to work for the birthing parent</li>
<li>Free daily catered lunch and dinner, and fully stocked kitchenette</li>
<li>Casual dress, flexible work hours, and regular catered team building events</li>
</ul>
</li>
<li>Compensation
<ul>
<li>As a growing company, the salary range is intentionally wide as we determine the most appropriate package for each individual taking into consideration years of experience, educational background, and unique skills and abilities as demonstrated throughout the interview process. Our intent is to offer a salary that is commensurate for the company's current stage of development and allows the employee to grow and develop within a role. </li>
<li>In addition to the significant stock option package, the estimated salary range for this role is $110,000-$200,000, inclusive of all levels/seniority within this discipline.</li>
</ul>
</li>
<li>Freeform is an Equal Opportunity Employer that values diversity; employment with Freeform is governed on the basis of merit, competence and qualifications and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability or any other legally protected status. </li>
</ul>

Senior Mechanical Engineer

<h3>Job Description</h3>
Job Description
Company Overview: Second Order Effects (SOE) is an engineering consulting firm that transforms uncertainty into fully functional hardware and software. We work on projects at all stages of development; we perform analysis, build prototypes, and take products to market. Our team solves high-impact problems across numerous industries, including automotive, aerospace, consumer electronics, industrial automation, biomedical, and green energy. Our designs control rocket engines, manage satellite communications, instrument fusion reactors, and are enjoyed by consumers around the world. The only thing we won't build is weapons.
Founded in 2016, Second Order Effects has 50+ employees (and counting!) in offices in El Segundo, California and Redmond, Washington. We've worked with &gt;130 clients on &gt; 300 projects as a partner, on retainer, or on demand.
How do we do this? We empower others, build the right thing, lead with curiosity, and own the outcome. Learn more at soeffects.com!
Job Overview: As a Senior Electrical Engineer, you'll play a pivotal role in shaping the design, architecture, and implementation of cutting-edge electrical systems across a diverse range of projects. Joining a growing organization, you will have the unique opportunity to mentor and guide early-career engineers while directly influencing and improving engineering processes. If you're passionate about being a technical mentor, tackling mission-critical challenges, and driving innovation across industries, this is your chance to make a lasting impact and grow in a dynamic environment. What You Will Do: 
<ul>
<li>Own the technical direction of project teams ranging from 3-10 engineers, aligning different disciplines towards shared solutions </li>
<li>Mentor early-career engineers, dedicating 30-50% of your time to skill development and feedback</li>
<li>Provide technical leadership in mixed-signal design, power electronics, digital design, or electrical systems integration</li>
<li>Drive the project lifecycle from inception to customer success, ensuring alignment with customer needs</li>
<li>Support business development efforts by engaging in early-stage calls and reviewing cost and labor estimates </li>
</ul>
What You Will Need:
<ul>
<li>Bachelor's Degree in Electrical Engineering, Computer Engineering, Physics, Math, or a related field</li>
<li>5+ years of experience designing custom electronics, with a track record of developing high-performance electronic products or systems.</li>
<li>Proven ability to lead project teams and deliver complex hardware design projects</li>
<li>Experience mentoring early-career engineers and facilitating their technical growth</li>
<li>Excellent problem-solving skills and initiative to overcome technical and non-technical challenges</li>
<li>Strong communication skills to explain complex technical concepts to both technical and non-technical stakeholders</li>
</ul>
What Would Be Useful:
<ul>
<li>Master's degree or graduate research experience in a relevant field</li>
<li>Experience in startup, tech, or consulting environments, managing multiple responsibilities simultaneously </li>
<li>Flexibility to pivot between projects and balance workload across teams </li>
<li>Passion for tackling diverse technical challenges across industries</li>
<li>Experience designing PCBs for high-reliability applications (e.g., aerospace, automotive, medical)</li>
</ul>
Benefits:
<ul>
<li>Compensation range of $151,100-$183,400 + equity incentive plan</li>
<li>Flexible work hours and work from home policy </li>
<li>100% employer-paid health insurance (Medical, Dental, Vision) for employees + 50% dependent coverage</li>
<li>Unlimited paid time off policy, 11x paid company holidays, 12x paid sick days</li>
<li>401(k) retirement account and employer matching (Safe Harbor 4%)</li>
<li>Generous paid parental leave</li>
<li>Relocation assistance available if 50+ miles away from the office</li>
<li>Daily catered lunches, snacks, and accessible kitchen</li>
</ul>
Additional Requirements: 
<ul>
<li>Applicant must be willing to work 40 hours a week on-site in Redmond, Washington, USA</li>
<li>Applicant must be eligible to work on export controlled projects</li>
<li>Job Type: Full-time (Salary)</li>
</ul>
Export Control Requirements:
<ul>
<li>To conform with U.S. Government export control regulations, including the Export Administration Regulations (EAR), you must be a U.S. citizen, lawful permanent resident of the U.S., protected individual as defined by 8 U.S.C. 1324b(a)(3), or eligible to obtain the required authorizations from the U.S. Department of State. Unfortunately, we are unable to provide sponsorship at this time.</li>
</ul>
If you don't meet 100% of the preferred skills and experience, we encourage you to still apply! Second Order Effects is proud to be an Equal Opportunity Employer; employment with SOE is governed on the basis of excellence and will not be influenced in any manner by race, color, religion, gender, national origin/ethnicity, veteran status, disability status, age, sexual orientation, gender identity, marital status, mental or physical disability, or any other legally protected status.

Senior Electrical Engineer

<h3>Job Description</h3>
Job DescriptionDescription:
Job purpose
 
The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&amp;D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above.
 
Duties and responsibilities
 
<ul>
<li>Plan and execute process optimization, equipment qualification, and process validation or process qualification projects.</li>
<li>Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements.</li>
<li>Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports.</li>
<li>Lead efforts to solve problems using formal problem resolution techniques and root cause analysis.</li>
<li>Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan.</li>
<li>Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team.</li>
<li>Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards. </li>
<li>Assess processes, take measurements, and interpret data.</li>
<li>Develop and monitor process and equipment metrics to use for optimization analysis.</li>
<li>Comply with FDA and AATB tissue banking standards.</li>
<li>Other duties as assigned.</li>
</ul>
 
Requirements:
Qualifications
 
Qualifications include:
<ul>
<li>BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus.</li>
<li>1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred.</li>
<li>Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills.</li>
<li>Ability to effectively communicate with multidisciplinary teams. </li>
<li>Excellent technical skills and writing.</li>
<li>Strong knowledge of LEAN manufacturing principles preferred.</li>
<li>Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred.</li>
<li>Proficient in project planning software. Microsoft Project preferred.</li>
<li>CTBS certified (or certified within two years of employment).</li>
<li>Strong work ethics.</li>
</ul>
 
Working conditions
 
Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. 
 
Physical requirements
 
The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans.
 
Direct reports
No direct reports

Process Engineer I

<h3>Job Description</h3>
Description
The Project Manager, Combination Products Development is accountable for leading the cross functional team (Engineering, Quality, Supply Chain, Marketing, Operations, Human Factors, and External Partners) in the execution of a portfolio of projects focused on the delivery system constituent parts of a combination product (Devices, Accessories, Instructions for Use, etc.). The Project Manager ensures that the strategy and plans defined for assigned programs are aligned with the needs of the patient and customer and the business objectives of the CMC and Product Strategy teams. In addition, product development timing and scope need to support plans for CMC gate reviews and each clinical phase.
 
Top 3-5 skills, experience or education required Skill:
1- Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success.
2- Communication: Excellent written and verbal communication skills to manage stakeholders and team members.
3- Risk Management: Expertise in identifying, assessing, and mitigating project risks.
4- Scheduling &amp; Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools.
5- Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements.
 
Education:
Required: Bachelor’s degree in engineering (mechanical or biomedical engineering).
Preferred: Master’s degree in engineering or management is preferred but not required.
Certification: Project Management Professional (PMP) Certification preferred but not required.
 
Experience:
8+ years of experience in the combination product or medical device industry with proven experience in developing medical devices or combination products; broad experience in design controls, human factors studies, design verification/validation and usability studies.
 
Summary of Responsibilities and Accountabilities:
The Project Manager will be accountable to the Program Manager Director for delivering on the strategy, plans and budget defined for the project portfolio.
 
Responsibilities include:
<ul>
<li>Leadership of a portfolio of drug delivery system product development projects</li>
<li>Tactical and strategic management of external device partners including acting as a key interface, managing the project governance process and forward-looking evaluation of potential partners</li>
<li>Device financial management including budgeting, forecasting and long-range planning of delivery development expenses</li>
<li>Representing the R&amp;D organization to cross functional leadership through effective and timely communication</li>
<li>Ensuring effective use of meetings by clearly defining objectives, agendas, inviting the team members specifically needed and publishing minutes and actions</li>
</ul>
 
Required Skills:
<ul>
<li>Leadership: Ability to motivate teams, delegate tasks effectively, and drive project success.</li>
<li>Communication: Excellent written and verbal communication skills to manage stakeholders and team members.</li>
<li>Risk Management: Expertise in identifying, assessing, and mitigating project risks.</li>
<li>Scheduling &amp; Organization: Proficiency in planning, prioritizing tasks, managing timelines, and using project management tools.</li>
<li>Problem-Solving/Process Improvement: Strong analytical skills to resolve issues and adapt to changing project requirements. Requires an in-depth understanding of the pharmaceutical and device product development cycle.</li>
<li>Design history file, project management and product development experience is essential.</li>
</ul>
 
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit <a href="http://www.ustechsolutions.com" target="_blank">www.ustechsolutions.com</a>.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
 
Job ID#25-47717
Recruiter - <a href="mailto:Rohit.n@ustechsolutions.com" target="_blank">Rohit.n@ustechsolutions.com</a>

Mechanical Design Engineer

<h3>Job Description</h3>
Description
Job Summary
Acts as technical subject matter expert on medical device connectivity and provides expert knowledge in developing and maintaining interfaces in a healthcare environment. Ensures effective and safe procurement, deployment, and sustainment of integrated medical devices/systems. Serves as a medical device/system subject matter expert to clinical staff, vendors, and the Clinical Engineering department. Supports, among others, the following integrated medical devices/systems: patient monitoring, nurse call, infusion pumps, vital signs, EEG, perfusion systems, OR video integration, cardiology ultrasounds, interactive patient systems, environmental monitoring systems, DICOM nodes, post-processing software, gastrointestinal systems, digital dental systems and review/acquisition software, HL7 brokers, Cerner EMR, and CMMS. Oversees multiple medical device/system projects with diverse stakeholders, timelines, and resources. Sustains medical device/system hardware, software, firmware, networking, servers, clients, databases, and interfaces with the support of clinical staff, in-house technical resources, and vendors. Sustainment scenarios include resolving end-user issues, supporting downtimes, requesting feature requests, performing vendor remediation, and responding to recalls or patient incident investigations.
Job Specific Duties
<ul>
<li>Serves as a medical device/system subject matter expert to clinical staff, vendors, and the Clinical Engineering department.&nbsp;</li>
<li>Responsible for the assessment, design, procurement, installation, monitoring, maintenance, troubleshooting, documentation, configuration, performance, and testing of medical device/system hardware, software, firmware, networking, servers, clients, databases, and interfaces with the support of clinical staff, in-house technical resources, and vendors.&nbsp;&nbsp;</li>
<li>Responsible for resolving end-user issues, supporting downtimes, requesting feature requests, performing vendor remediation, and responding to recalls or patient incident investigations.</li>
<li>Develops and maintains an up-to-date inventory and technical reference documentation of medical devices/systems and their interconnections for use in end-user issues, downtimes, feature requests, vendor remediation, recalls, repairs, upgrades, incident investigations, or capital planning.&nbsp;</li>
<li>Oversees and participates in multiple medical device/system projects with diverse stakeholders, timelines, and resources.&nbsp;&nbsp;</li>
<li>Monitors and adopts the industry's and health system's latest best practices for integrated medical devices/systems, specifically for risk assessments, IT change management, FDA or vendor hazard/recalls, or patient incident root cause analysis.</li>
<li>Juggles multiple medical device/system issues requiring adequate response, delegation, prioritization, or escalation.&nbsp;</li>
<li>Participates in a rotating on-call schedule to respond to medical device/system end-user issues and device/system downtimes in a 24/7/365 environment.&nbsp;</li>
<li>Provides functional and technical guidance to assigned personnel on a daily basis including scheduling, monitoring, reviewing of systems studies, project and program.&nbsp;</li>
</ul>
Qualifications
Minimum Job Requirements
<ul>
<li>Bachelor's Degree in Biomedical Engineering or related major (OR) 5+ years of equivalent relevant experience.</li>
<li>4-7 years of hands-on experience in medical systems configuration and administration.</li>
<li>4-7 years of experience designing, implementing, and supporting clinical application systems.</li>
<li>4-7 years of work experience with SQL Server relational database systems.</li>
<li>4-7 years of work experience in HL7 interface engines.</li>
</ul>
Knowledge, Skills, and Abilities
<ul>
<li>Healthcare Technology Management and Information Technology relevant certifications strongly preferred.</li>
<li>Ability to communicate effectively both verbally and writing.</li>
<li>Strong working knowledge of healthcare technology management, project management, information technology, and process improvement.</li>
<li>Strong working knowledge of Windows OS, MAC OS, Linux OS, HL7 brokers, XML, JAVA, SQL, DICOM, and Cerner EMR.</li>
<li>Strong working knowledge of patient monitoring, nurse call, infusion pumps, vital signs, EEG, perfusion, OR/Cath Lab video integration, Cardiology device/systems, interactive patient systems, environmental monitoring systems, DICOM nodes, post processing software, gastrointestinal systems, dental systems, HL7 brokers, and CMMS.</li>
<li>Strong soft skills (communication, flexibility, leadership, teamwork, time management, creativity, ability to work under pressure, self-motivation, accountability, etc.)</li>
<li>Practical experience with project delivery and systems development.</li>
<li>Experience in leading hospital applications suites preferred.</li>
<li>Working knowledge of HL7 standards and custom interface products.</li>
<li>Strong understanding of enterprise Wide Area Network (WAN), Local Area Network (LAN), TCP/IP, Ethernet.</li>
</ul>
 Job : Information Technology Department : CLINICAL ENGINEERING-2100-810000 Job Status :Full Time

Clinical Engineer System Integration II

<h3>Job Description</h3>
Job Description
Overview
Now Hiring Field Service Engineer Ultrasound!Location: Washington, DC*Some regional travel may be required*Salary: Starting at $60,000 annually based on experience. Who We Are:
Tri-Imaging Solutions is at the forefront of medical imaging equipment innovation, specializing in enterprise imaging systems management. We’re committed to delivering cutting-edge solutions and empowering our team with the tools, training, and opportunities to grow. Join our dynamic team and play a vital role in advancing healthcare technology.
Why Join Us (Benefits):
<ul>
<li>
Highly competitive salary
</li>
<li>
Car/travel reimbursement
</li>
<li>
Continuing diagnostic imaging training (with a path into advanced modalities like CT, MRI, and Cath Lab)
</li>
<li>
Company-paid holidays plus PTO
</li>
<li>
Major medical/dental/vision benefits
</li>
<li>
Recognition/reward program
</li>
</ul>
Position Overview:
We are seeking a motivated Level 1 Field Service Engineer with a primary focus on ultrasound systems. This is an excellent opportunity for early-career professionals with a strong technical foundation who want to expand into other diagnostic imaging modalities over time. The right candidate will receive structured training and mentorship to build expertise across the full spectrum of imaging technology.
What You’ll Do:
<ul>
<li>
Perform installations, calibrations, inspections, and basic repairs on general ultrasound equipment
</li>
<li>
Conduct preventive maintenance in accordance with OEM specifications
</li>
<li>
Use laptop-based diagnostic tools and hand tools to assess and improve system performance
</li>
<li>
Collaborate closely with senior engineers to develop advanced troubleshooting skills
</li>
<li>
Provide excellent customer service while ensuring equipment operates to the highest safety and performance standards
</li>
<li>
Travel to client sites within the assigned territory
</li>
</ul>
What You’ll Need (Requirements):
<ul>
<li>
Associate degree in Biomedical Engineering, Electrical Engineering, or related field, or equivalent work experience
</li>
<li>
1–2 years of hands-on experience as a biomedical or ultrasound service technician
</li>
<li>
Strong mechanical aptitude and diagnostic skills
</li>
<li>
Eagerness to learn other imaging modalities such as CT, MRI, and Cath Lab
</li>
<li>
Excellent communication and teamwork abilities
</li>
<li>
Willingness to travel regionally as needed
</li>
</ul>

Field Service Engineer Ultrasound

<h3>Job Description</h3>
Job Description
Are you a mechanical maestro ready to unleash your expertise? At BDC Laboratories, we invite you to immerse yourself in an exhilarating role as a Full-Time Product Evaluations Engineer III onsite in Wheat Ridge, CO. This isn’t just any gig; it’s an opportunity to innovate and solve real-world problems, all while collaborating with a vibrant team that values customer satisfaction above all.
As you dive into engaging projects that drive the biotech industry forward, you'll enjoy a competitive salary ranging from $95,000 to $112,000. Here, your ingenuity and keen eye for excellence will be recognized, not just encouraged. The thrill of working in a dynamic, energetic environment awaits you!
You will be provided great benefits such as Medical, Dental, Vision, 401(k), Health Savings Account, and Paid Time Off. Don’t miss the chance to be at the forefront of biotechnology, where every day is a new adventure. Elevate your career with us today!
Let us introduce ourselves
Biomedical Device Consultants &amp; Laboratories (<a href="http://www.bdclabs.com" target="_blank">www.bdclabs.com</a>) is a fast-growing company that offers comprehensive medical device testing services, designs verification test equipment, and produces silicone mock vessels to the medical device community in support of domestic and international regulatory submissions and approvals. Our primary focus is cardiovascular technologies such as endovascular stents, prosthetic heart valves, and catheters. As a small company, BDC's environment is fast-paced, dynamic, challenging, and rewarding.
Your day to day as a Product Evaluations Engineer III
As a Full-Time Product Evaluations Engineer III at BDC Laboratories, your mission is to ensure that every piece of equipment meets the rigorous demands of our biotech studies. You’ll assess the suitability of equipment for data acquisition, ensuring compliance with protocol specifications. Your expertise will keep our laboratory inspection-ready, as you guarantee all equipment is designed for optimal performance, adequately cleaned, and meticulously maintained. You'll lead the way in establishing innovative test methods, preparing meticulous protocols, and maintaining a contamination-free environment.
Each data entry you record will enhance the integrity of our research, as you diligently verify and analyze experimental data. Additionally, you will play a key role in supporting our Quality Management System and participating in audits, all while setting an exemplary standard for your colleagues. This position is not just about maintaining excellence; it's about driving innovation in a fun, high-performance culture.
Requirements for this Product Evaluations Engineer III job
To thrive as a Full-Time Product Evaluations Engineer III at BDC Laboratories, you’ll need a robust toolkit of skills and experiences. A minimum of a Bachelor’s Degree in engineering or a science-based field, coupled with relevant years of experience, establishes your foundational expertise. Familiarity with quality system requirements like ISO 17025 and 21 CFR Part 58 is preferred, while knowledge of ISO 13485 and 21 CFR Part 820 will set you apart. Your analytical and problem-solving prowess will be crucial, allowing you to perform statistical analyses and interpret technical regulations effectively. Strong verbal and written communication skills are essential for drafting clear protocols and presenting information to both managers and team members.
Additionally, your ability to mentor and manage fellow engineers will contribute to a dynamic and collaborative team environment. Embrace this opportunity to lead with integrity in a forward-thinking biotech space!
Knowledge and skills required for the position are: 
<ul>
<li>Minimum of a Bachelor’s Degree in an engineering field and 4 years of experience; or minimum of a Master’s Degree in an engineering field and 2 years of experience; or minimum of a Bachelor’s Degree in a science-based field and 6 years of relevant experience; or an Associate Degree with a minimum of 10 years of relevant experience.</li>
<li>Understanding of quality system requirements including ISO 17025 and 21 CFR part 58 is preferred. Experience in 21 CFR Part 820 and Part 11, ISO 13485 and other relevant international standards desirable.</li>
<li>Must be organized with excellent analytical and problem-solving abilities and the ability to perform and report basic statistical analyses.</li>
<li>Ability to read analyze and interpret technical procedures and governmental regulations; along with the ability to effectively present information and respond to questions from managers and team members. Ability to effectively draft protocols and reports.</li>
<li>Ability to define problems, collect data, establish facts and draw valid final conclusions.</li>
<li>Strong verbal and writing skills and good interpersonal and leadership skills.</li>
<li>Proficiency with a Windows environment(Word and Excel) required.</li>
<li>Experience managing other engineers.</li>
</ul>
Get started with our team!
If you feel that this job is what you're looking for, applying is a piece of cake - just follow the instructions on this page. Good luck!
 Job Posted by ApplicantPro

Product Evaluations Engineer III

<h3>Job Description</h3>
Job Description
Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines &amp; Values:
<ul>
<li>We empower and support our colleagues</li>
<li>We commit to client success at every turn</li>
<li>We have the courage to do the right thing</li>
<li>We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.</li>
<li>We constantly acquire new skills and learn from our experiences to enhance our collective expertise</li>
</ul>
CQV Engineer Responsibilities (Typical):
<ul>
<li>Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis</li>
<li>Supporting clients change management program – including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release</li>
<li>Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader</li>
<li>Running test scripts and documenting results</li>
<li>Adherence with project schedule for all assigned activities</li>
<li>Maintaining clear, detailed records qualification and validation</li>
<li>Documenting impact and risk assessments as part of a team</li>
<li>Completing user interface testing, software verification, and complete alarm testing on automated systems</li>
<li>Developing, reviewing, and executing testing documentation</li>
<li>Making recommendations for design or process modification based on test results when executing test scripts</li>
<li>Reading technical schematics to identify, locate, and test photo sensors, verify part numbers, and complete I/O testing on automated manufacturing equipment</li>
<li>General understanding of capital equipment implementation and process knowledge</li>
<li>Understanding validation documents, URS, IQ, OQ, PQ</li>
<li>Verifying system drawings including ability to review and as-built P&amp;IDs (piping and instrumentation drawings) and I&amp;C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer</li>
</ul>

Requirements:
<ul>
<li>Must be able to meet onsite work requirements in Holly Springs, NC</li>
<li>Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)</li>
<li>2-4 years of relevant industry experience</li>
<li>Proficiency using PC and Microsoft Office tools</li>
<li>Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms</li>
<li>Ability to work as part of a team</li>
<li>Strong problem-solving and critical thinking skills</li>
<li>Excellent organizational and time management skills</li>
<li>Strong attention to detail</li>
<li>GMP and Good Documentation Practice training (may be completed at onboarding)</li>
<li>Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes)</li>
<li>Basic skills with EXCEL and PowerPoint</li>
<li>Strong interpersonal skills and clear communication capabilities</li>
</ul>
For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range$65,000—$104,439 USD
Benefits
Why Choose Verista?
<ul>
<li>High growth potential and fast-paced organization with a people-focused culture</li>
<li>Competitive pay plus performance-based incentive programs</li>
<li>Company-paid Life, Short-Term, and Long-Term Disability Insurance.</li>
<li>Medical, Dental &amp; Vision insurances</li>
<li>FSA, DCARE, Commuter Benefits</li>
<li>Supplemental Life, Hospital, Critical Illness and Legal Insurance</li>
<li>Health Savings Account</li>
<li>401(k) Retirement Plan (Employer Matching benefit)</li>
<li>Paid Time Off (Rollover Option) and Holidays</li>
<li>As Needed Sick Time</li>
<li>Tuition Reimbursement</li>
<li>Team Social Activities (We have fun!)</li>
<li>Employee Recognition</li>
<li>Employee Referral Program</li>
<li>Paid Parental Leave and Bereavement</li>
</ul>
Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details. 
For more information about our company, please visit us at Verista.com

5832- CQV Engineer / Validation Engineer 2

<h3>Job Description</h3>
Job Description&nbsp;Product Engineer III Buffalo, NY $88,000-$91,000/year&nbsp;and Benefits Include&nbsp;- Health, Dental, and Vision insurance, 401K, Paid holidays and vacations, Tuition reimbursement program, Quarterly bonuses, Subsidized cafeteria costs, Peer recognition initiatives, Summer scholarships for children and grandchildren of employees, On-site gym.&nbsp;&nbsp;&nbsp;&nbsp;DescriptionJob Summary The Senior Product Engineer III, resolves complex issues while planning, designing, and developing new products and manufacturing processes according to customer specifications and in accordance with company standard operating procedures by performing the following job duties. Job Duties
<ul>
<li>Coordinates development and startup activities with internal departments and customers. Manages and maintains project schedules to meet internal and customer deadlines.</li>
<li>Review customer specifications and needs. Translates this data into product engineering specifications.</li>
<li>Outlines materials, processes, tooling, and labor content.</li>
<li>Prepares prints, bills of material, process documentation, and other engineering documents.</li>
<li>Designs, develops, qualifies, and validates manufacturing tooling, equipment, and processes</li>
<li>Maintains engineering documents to reflect customer, vendor, or internal specifications changes.</li>
<li>Remains alert to new technologies (including process, materials, and equipment) which can improve cost margins, manufacturability, safety, throughput, and yields.</li>
<li>Assists sales department in estimating materials, labor, and tooling for preparation of quotations.</li>
<li>Leads Customer Projects and works directly with Customers on Schedule, Qualifications, and all aspects of project from the start through completion.</li>
<li>Develops and designs Product Line Improvements to improve Quality, Throughput, or Cost.</li>
<li>Mentors new Product Engineers.</li>
<li>Demonstrates Company core values of honesty, integrity, and respect.</li>
<li>Other duties as assigned.</li>
</ul>
&nbsp;Impact
<ul>
<li>Ensure cost containment levels are maintained</li>
<li>Recommend, design, develop manufacturing process/procedure improvements</li>
<li>Analyze potential areas for savings or efficiencies.</li>
</ul>
&nbsp;Safety Responsibilities
<ul>
<li>Following all rules, regulations, and procedures set forth in the safety manual.</li>
<li>Promoting safety awareness throughout the workplace.</li>
<li>Alerting supervisors to any safety hazards they discover.</li>
<li>Wearing appropriate, proper protective equipment whenever required.</li>
<li>Using guards on tools and machinery whenever required.</li>
<li>Following proper lifting techniques using legs and not the back.</li>
<li>Operating any vehicles, equipment, tools, or machines only if they are authorized to do so.</li>
<li>Reporting any injury or loss immediately to the supervisor/team lead.</li>
<li>Promoting a positive attitude about safety and never performing any unsafe practice that could place the employee or others in danger.</li>
<li>Providing information to their immediate supervisor if a better and safer procedure can be implemented in performing any operation.</li>
<li>Assure when designing or modifying equipment/workstations that ergonomics and safety are reviewed and work to minimize hazards through engineering controls, administrative controls, and lastly personal protective equipment.</li>
<li>Assure Job Hazard and Equipment Hazard Analysis are completed timely as required per MNG.008.</li>
</ul>
&nbsp;Independent Judgment
<ul>
<li>Decide which projects are priority relative to company goals</li>
<li>Determine best-in-class frameworks, systems and processes</li>
</ul>
&nbsp;Analysis/Problem Solving
<ul>
<li>Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.</li>
<li>Ability to advance mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.</li>
<li>Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.</li>
<li>Ability to define problems, collect data, establish facts, and draw valid conclusions.</li>
<li>Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.</li>
</ul>
&nbsp;Communication
<ul>
<li>Ability to write reports, business correspondence, and procedure manuals.</li>
<li>Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.</li>
</ul>
&nbsp;&nbsp;Experience
<ul>
<li>7+ years related experience and/or training.</li>
<li>Understands regulated type industries.</li>
<li>Plastics experience a huge plus. Medical or regulated environment with ISO and/or FDA certification strongly preferred (ISO 13485/ISO 14971 and 21 CFR Part 820 huge plus).</li>
<li>World-class manufacturing knowledge preferred.</li>
</ul>
Analysis/Problem Solving
<ul>
<li>Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.</li>
<li>Ability to advance mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.</li>
<li>Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.</li>
<li>Ability to define problems, collect data, establish facts, and draw valid conclusions.</li>
<li>Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with abstract and concrete variables.</li>
</ul>
&nbsp;Communication
<ul>
<li>Ability to write reports, business correspondence, and procedure manuals.</li>
<li>Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.</li>
</ul>
&nbsp;Skills/Technical Skills
<ul>
<li>Communication Skills</li>
<li>Computer skills required, including Microsoft Office Applications, Lotus Notes, Graphic applications, E-mail, and other related task-specific software.</li>
<li>Product design and validation, Solid Works, 6 sigma, Minitab/Excel, Project Management Professional, Root Cause Investigations, Mechatronics, Mechanical Design, specification review, Drafting/qualifications, IQ, OQ, PQ. &nbsp;</li>
</ul>
&nbsp;&nbsp;Physical Requirements
<ul>
<li>While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.</li>
</ul>
&nbsp;Education
<ul>
<li>Bachelors + 7 years in Mechanical, Industrial, and/or Biomedical/ Biomechanical Engineering.</li>
</ul>
If you meet the above qualifications and would like to apply for this position, please click APPLY NOW and upload your most current resume or you may email your resume to our recruiter,&nbsp;Christine Hannon at Please include&nbsp;PRODUCT&nbsp;3 on the subject line of any e-mail correspondence. Questions regarding this position can be addressed by emailing.&nbsp; Thank you in advance for applying, however, only qualified candidates will be contacted. The Adecco Group is a Fortune Global 500 company and the global leader in Human Resource Solutions. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your Professional Career. For great opportunities near you, go to&nbsp;<a href="http://www.adeccousa.c" target="_blank">www.adeccousa.c</a>om&nbsp;today! &nbsp; Pay Details: $88,000.00 to $91,000.00 per year Equal Opportunity Employer/Veterans/Disabled To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to <a href="https://uat.adecco.com/en-us/candidate-privacy" target="_blank">https://uat.adecco.com/en-us/candidate-privacy</a> The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: 
<ul>
<li>The California Fair Chance Act</li>
<li>Los Angeles City Fair Chance Ordinance</li>
<li>Los Angeles County Fair Chance Ordinance for Employers</li>
<li>San Francisco Fair Chance Ordinance</li>
</ul>
 
Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Sr Product Engineer III

<h3>Job Description</h3>
Job DescriptionR&amp;D Sustaining Engineer
100% ONSITE - Westlake Village CA
(This role is not eligible for work visa sponsorship)
Caldera Medical’s Mission - To Improve the Quality of Life for Women!
 
Message from the Hiring Manager: The R&amp;D Sustaining Engineer will lead projects and provide technical expertise to ensure the ongoing reliability, compliance, and cost-effectiveness of our existing medical device products. This role is crucial for supporting products throughout their lifecycle by resolving manufacturing issues, implementing design changes, and leading continuous improvement initiatives. The engineer will collaborate with cross-functional teams, including manufacturing, quality, supply chain, and regulatory affairs, to address challenges and maintain product quality. 
Duties and Responsibilities: 
Project Leadership: Lead small to intermediate-sized sustaining engineering projects, including product and process improvements, cost reduction initiatives, and component obsolescence management.
Manufacturing Support: Act a primary R&amp;D resource for manufacturing and production issues. Work closely with the manufacturing engineering team to troubleshoot and perform root cause analysis on product and process failures and implement effective corrective and preventive actions (CAPAs).
Design and Process Changes: Coordinate and complete the following as needed for all sustaining engineering objectives:
a. Project Schedule
b. Quality and Regulatory documents
c. Labeling and IFU changes
d. Design Requirements - Trace Matrix
e. Design Specifications - Trace Matrix
f. Real Time Aging retention, testing
g. V&amp;V testing, documentation
h. Testing protocols and reports
i. Support Engineering Evaluation of returned product when needed.
j. Competitive product evaluation including standard testing
k. Support change Orders, technical review, implementation when needed
 Required Knowledge, Skills and Abilities:
Education: Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
Experience: 4+years of experience in a regulated industry, with a strong emphasis on medical device product development or sustaining engineering. Experience with Class II or Class III medical devices is preferred. Experience in medical device component and material processing, design, and manufacturing. A comprehensive understanding of ISO, GMP and FDA regulations for the development.
Other Requirements:
1. Strong analytical and problem-solving skills and comprehensive understanding of design control processes, risk management, and validation of processes/designs.
2. Proven project management skills.
3. Experience with lean manufacturing and continuous improvement methodologies
4. Effective verbal, presentation and written communication skills.
5. Proficient in Microsoft Office, and MS project.
6. Working experience in Solidworks.
7. Working knowledge of medical device development, sterilization requirements and techniques, and medical device regulations.
8. Additional responsibilities may be assigned as needed to support business objectives.
Travel Required
<ul>
<li>10%</li>
</ul>
Competitive Compensation, Comprehensive Benefits, and more!
<ul>
<li>100k-$120k Annual Salary</li>
<li>Medical and Dental Benefits – 75% paid for employee and family members</li>
<li>Vision Coverage</li>
<li>401(k) with 4% matching contributions after 90 days of employment</li>
<li>Basic Life and AD&amp;D</li>
<li>Unlimited Vacation Policy</li>
<li>6 Weeks Paid Maternity Leave</li>
<li>10 paid holidays- including your birthday!</li>
<li>Being surrounded by amazing people!</li>
</ul>
(This role is being filled directly by our in-house recruiting team. We are not working with outside agencies for this position.)
Our Culture- Where Career and Passion come together!
<ul>
<li>A Culture of family and team… not a corporate goliath where you’re just another number.</li>
<li>All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.</li>
<li>The Women’s Health Initiative is the heart of what we do, every day we put underprivileged women first.</li>
<li>Our goal is to treat 1 million women suffering from incontinence by 2027!</li>
</ul>
Who is Caldera Medical?
Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.
Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.

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