Genesis10 is currently seeking a Test Engineer for a 6+ month contract to hire position with a Global Medical Technology Company located in San Diego, CA.
Compensation: $58.00 - $68.00 per hour, W2, based on qualifications
Position Overview: This role focuses on mechanical and electromechanical design verification testing for CGM applicator and wearable systems. The ideal candidate will collaborate with engineering, sterilization, and packaging teams to define product requirements, execute test strategies, and ensure compliance with medical device standards.
Key Responsibilities: - Collaborate with Mechanical Engineering, Sterilization, Packaging, and cross-functional teams to define product requirements, test strategies, and use cases for CGM applicator and wearable systems
- Lead and execute design verification strategies for mechanical and electromechanical assemblies, including applicator deployment mechanisms, sensor insertion systems, and housing retention features
- Design and implement cost-effective test methods for mechanical and electromechanical systems, including force measurements, deployment testing, water ingress protection (IPX8), and environmental conditioning
- Create and maintain verification documentation, including test plans, protocols, and reports in compliance with ISO 13485, 21 CFR 820, and applicable IEC/ASTM standards
- Analyze test results using statistical techniques (e.g., t-test, ANOVA, tolerance intervals, equivalence testing), document findings accurately, and provide improvement recommendations
- Plan and execute assessment of sterilization impact on mechanical performance and sensor deployment integrity
- Support distribution simulation, environmental conditioning, and packaging verification activities in coordination with packaging engineering
- Seek opportunities to improve processes, test equipment, and methods, including elimination of non-value-added activities or automation of tedious tasks and tests
- Design, fabricate, and troubleshoot test fixtures and equipment
Primary Requirements: - Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline
- 5+ years of relevant experience
- Experience with mechanical testing methods including force measurement, displacement, deployment mechanisms, and environmental testing (temperature, humidity, vibration, shock)
- Statistical analysis experience (JMP, Minitab)
- A self-driven, technical person with strong interpersonal skills and the ability to manage multiple projects simultaneously
- Medical device industry experience
Desired Skills: - Familiarity with relevant standards such as IEC 60601-1, IEC 60601-1-11, ASTM D4169, ASTM D4332, ISTA 3A, and ISO 11607
Only candidates available and ready to work directly as Genesis10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply! Ranked a Top Staffing Firm in the U.S. by Staffing Industry Analysts for six consecutive years, Genesis10 puts thousands of consultants and employees to work across the United States every year in contract, contract-for-hire, and permanent placement roles. With more than 300 active clients, Genesis10 provides access to many of the Fortune 100 firms and a variety of mid-market organizations across the full spectrum of industry verticals.
For contract roles, Genesis10 offers the benefits listed below. If this is a perm-placement opportunity, our recruiter can talk you through the unique benefits offered for that particular client. Benefits of Working with Genesis10: - Access to hundreds of clients, most who have been working with Genesis10 for 5-20+ years
- The opportunity to have a career-home in Genesis10; many of our consultants have been working exclusively with Genesis10 for years
- Access to an experienced, caring recruiting team (more than 7 years of experience, on average)
- Behavioral Health Platform
- Medical, Dental, Vision
- Health Savings Account
- Voluntary Hospital Indemnity (Critical Illness & Accident)
- Voluntary Term Life Insurance
- 401K
- Sick Pay (for applicable states/municipalities)
- Commuter Benefits (Dallas, NYC, SF, and Illinois)
For multiple years running, Genesis10 has been recognized as a Top Staffing Firm in the U.S., as a Best Company for Work-Life Balance, as a Best Company for Career Growth, for Diversity, and for Leadership, amongst others. To learn more and to view all of our available career opportunities, please visit us at our website.
Genesis10 is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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