remote
Senior Quality Engineer - Hardware - Tandem Diabetes Care, Inc.
Software Engineer
Lead hardware quality initiatives for advanced insulin delivery systems, driving rigorous testing, failure analysis, and process improvement to meet ISO 13485 and FDA standards.
About the role
Key Responsibilities
- Design, execute, and document comprehensive hardware test plans for insulin pump components and control systems.
- Lead failure mode and effects analysis (FMEA) and root cause investigations to identify and mitigate hardware defects.
- Develop and maintain automated test scripts and data‑analysis pipelines to accelerate validation cycles.
- Collaborate with design, manufacturing, and regulatory teams to ensure compliance with ISO 13485 and FDA 21 CFR Part 820.
- Drive continuous improvement of test processes, metrics, and tooling to enhance product reliability and time‑to‑market.
Requirements
- Bachelor’s degree in Electrical Engineering, Biomedical Engineering, or related field.
- 5+ years of hardware quality engineering experience in medical device or high‑reliability industry.
- Proficiency in statistical process control, FMEA, and failure analysis techniques.
- Strong analytical skills with experience in test automation and data‑driven decision making.
- Excellent communication and cross‑functional collaboration abilities.
Skills
software developmentsystem designproblem solving