Test Engineer - Onsite

Test Engineer

Genesis
10 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. 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.

• 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

• 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

• 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 Genesis
10 employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, please apply!