Test Engineer 3-USD

Design and implement cost-effective test methods for mechanical and electromechanical systems, including force measurements, deployment testing, water ingress protection (IPX8), and environmental conditioning. Lead and execute design verification strategies for mechanical and electromechanical assemblies, including applicator deployment mechanisms, sensor insertion systems, and housing retention features.

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.
Role Summary: This is a temporary position (6 months possibly more) to provide backup coverage for a team member. The role focuses on mechanical and electromechanical design verification testing for CGM applicator and wearable systems. Key responsibilities include deployment mechanism verification, environmental conditioning, sterilization impact assessment, force measurements, and IPX8 water ingress testing.
Key Qualifications:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related discipline (5 years of experience would be great)
Experience with mechanical testing methods (force measurement, deployment mechanisms, environmental testing)
Familiarity with IEC 60601-1, ASTM D4169, ASTM D4332, ISO 11607
Statistical analysis experience (JMP, Minitab)
Medical device industry experience preferred

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”