Senior Principal Quality Engineer – Design Quality & Systems Excellence

Position Summary

We are seeking a Senior Principal Quality Engineer to serve as a technical leader and change agent driving design quality excellence across complex electro‑mechanical, software‑driven medical devices. This role partners deeply with engineering and design quality engineering to ensure robust product design through system engineering principles, design controls, and risk management integration. The successful candidate will lead high‑impact, cross‑functional initiatives to improve product reliability and robustness through reliability growth programs, design‑for‑portability, robust algorithm and sensor system validation, motor control verification, and end‑to‑end connectivity.

• Lead design quality strategy across NPD programs, ensuring products are robust, reliable, and compliant.
• Serve as the primary quality partner on product development teams, embedding quality‑by‑design principles from concept through commercialization and ensuring requirements traceability and design control compliance specifically for key Impella console features.
• Establish and deploy a Product Reliability Program (DfR, reliability modeling, growth strategies) including accelerated life testing, development of growth curves, statistical reliability demonstration, and test‑to‑failure strategies.
• Drive improvement of system‑level design documentation, including architecture, interfaces, and functional specifications in collaboration with systems engineering.
• Ensure excellence in design controls (design inputs/outputs, reviews, V&V, design transfer).
• Lead and integrate risk management activities (hazard analysis, FMEA, risk controls).
• Drive product quality improvement initiatives using field data, CAPA, and root cause analysis.
• Partner with Engineering and Quality teams to align on requirements, design intent, and verification strategies, providing hands‑on guidance on appropriate testing scenarios.
• Partner and collaborate with cross‑functional teams to implement improvements and ensure adherence to regulatory standards.
• Apply advanced statistical methods to support sampling strategies, reliability demonstration, and data‑driven decisions.
• Act as a change agent, driving cross‑functional alignment and adoption of best practices.
• Provide hands‑on technical guidance to develop robust, fault‑tolerant system designs.
• Solve technical problems and provide solutions that are technically sound and programmatically executable.
• Provide technical leadership, direction, and mentoring to other design quality and R&D engineering, coaching teams and acting as an escalation point for high‑risk technical quality issues.

• ISO 14971 – Risk Management for Medical Devices: leadership of end‑to‑end risk management, including hazard analysis, risk evaluation, and implementation of risk control measures.
• IEC 60601 – Medical Electrical Equipment Safety & Performance: translating 60601 requirements into design inputs and verification strategies.
• FMEA (System, dFMEA, sFMEA): leading cross‑functional FMEA activities for complex systems.
• Usability & Human Factors (IEC 62366): integrating human factors engineering into product development.
• ISO 13485 – Quality Management Systems: deep knowledge of ISO 13485‑compliant design controls and quality systems.
• Advanced Statistics & Sampling Expertise:
  • Define risk‑based sample sizes aligned with product risk and reliability targets.
  • Apply confidence intervals, reliability demonstration testing, and hypothesis testing.
  • Justify statistically sound sample sizes for regulatory and audit acceptance.
  • Balance deterministic and statistical approaches to ensure both efficiency and high confidence in design robustness.
  • Drive data‑driven decision making across NPD and post‑market activities.
• Practical application of statistics to reliability growth programs (Weibull/parametric models, confidence bounds for reliability demonstration, accelerated life test analysis).

• Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, Biomedical, or related field).
• 12–15+ years of experience in medical device development and quality engineering.
• Experience with…