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.

• 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 (reliability growth, portability, usability, algorithms/sensors, motor control, connectivity)

• Establish and deploy a Product Reliability Program (DfR, reliability modeling, growth strategies). This would include accelerated life testing, development of growth curves, statistical reliability demonstration, and test to failure strategies. Use field and verification data to prioritize focus and design changes

• Drive improvement of system‑level design documentation
  , including architecture, interfaces, and functional specifications in collaboration with systems engineering to ensure clear verification responsibility, testability and traceability for multi‑domain features (mechanical, electrical, software, algorithms, usability)

• 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. Lead cross‑functional failure investigations, ensure timely corrective actions, and verify effectiveness

• Partner with Engineering and Quality teams to align on requirements, design intent, and verification strategies
  . Provide hands‑on guidance on appropriate testing scenarios. Influence requirements definition to ensure they are measurable and verifiable

• Partner and collaborate with cross‑functional teams to implement improvements and ensure adherence to regulatory standards, impacting operational efficiency and product quality.

• Apply advanced statistical methods to support sampling strategies, reliability demonstration, and data‑driven decisions. Define risk‑based sampling strategies including verification and reliability demonstration, and apply techniques to support acceptance 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 in the application of system and ecosystems engineering principles, tools, and techniques to achieve practical end results. Coach teams and act as an escalation point for high‑risk technical quality issues. Regularly communicate and recommend mitigations to program and Sr. leadership using quantitative metrics

• ISO 14971 – Risk Management for Medical Devices Hands‑on leadership of end‑to‑end risk management
  , including hazard analysis, hazardous situations, risk evaluation, and implementation of risk control measures
  . Strong integration of risk management with design inputs, system requirements, and verification activities
  , ensuring traceability and regulatory compliance.

• IEC 60601 – Medical Electrical Equipment Safety & Performance Practical experience translating 60601 requirements into design inputs and verification strategies
  , including electrical safety, EMC, and essential performance. Proven ability to support compliance planning, testing, and certification readiness
  .

• FMEA (System, dFMEA, sFMEA) Extensive experience leading cross‑functional FMEA activities for complex systems. Strong capability in identifying failure modes, linking FMEA outputs to hazard analysis and design inputs
  , and driving risk mitigation and design improvements
  .

• Usability & Human Factors (IEC 62366) Hands‑on experience integrating human factors engineering in…