Senior Principal Quality Engineer – Design Quality & Systems Excellence

Johnson & Johnson Innovative Medicine • Danvers, MA

10d • $122,000 - $212,750 • Onsite

About The Position

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 strong system engineering principles, design controls, and risk management integration. The ideal candidate will lead high-impact, cross-functional initiatives to improve product reliability and robustness through reliability growth programs, design-for portability (ambulation and transport), robust algorithm and sensor system validation, motor control verification and end- to-end connectivity. The successful candidate will work as part of a product development team to translate system architecture, interfaces and trade-offs into robust and verifiable designs, as well as providing system-level design documentation, and ensuring overall product quality across the New Product Development (NPD) and marketed lifecycle.

Requirements

• 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.
• Practical experience translating IEC 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.
• 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.
• Hands-on experience integrating human factors engineering into product development. Skilled in developing user needs, performing use-related risk analysis, and translating usability findings into design requirements. Experience supporting formative and summative usability studies.
• Deep knowledge of ISO 13485-compliant design controls and quality systems, including design documentation, traceability, audit readiness, and continuous improvement. Experience supporting internal/external audits and regulatory inspections.
• Recognized expert in applying statistical methods to determine appropriate sampling strategies for design verification and validation. Proven ability to: 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) and using those results to inform go/no-go decisions for design iterations and product releases
• 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
• Electromechanical software products is required
• Extensive experience supporting New Product Development (NPD) programs
• Strong expertise in: Design controls and regulatory compliance System engineering principles Risk management and reliability engineering Advanced statistical methods and sampling strategies Electro-mechanical and software-integrated systems
• Demonstrated experience on product development teams working on console products (or equivalent complex electro-mechanical/embedded systems) where motor control, sensors/algorithms, portability (ambulation/transport), usability, and connectivity are primary design drivers

Nice To Haves

• Proven technical leader and change agent driving high-impact initiatives
• Strong ability to influence across Engineering, Quality, and Regulatory teams
• Hands-on, detail-oriented, with deep systems-level thinking
• Track record of improving product quality, reliability, and design rigor
• Recognized as a trusted partner to engineering and senior leadership
• Exceptional communicator with ability to translate technical risk and statistical results into clear program-level decisions.
• Comfortable working in fast-paced NPD environments and influencing product roadmap priorities based on quality and reliability tradeoffs

Responsibilities

• 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

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior