Senior Principal Quality Engineer – Design Quality & Systems Excellence

Senior Principal Quality Engineer – Design Quality & Systems Excellence

Danvers, Massachusetts, United States

Senior Principal Quality Engineer responsible for leading the technical direction and change initiatives that drive design quality excellence across complex electromechanical, software‑driven medical devices. Works closely with engineering and quality teams to embed quality‑by‑design principles from concept through commercialization, ensuring robust product design via system engineering, design controls, risk management, and reliability growth programs.

• Lead design quality strategy across new‑product‑development (NPD) programs, ensuring products are robust, reliable, and compliant.
• Primary quality partner on product development teams; embed quality‑by‑design, traceability, and design control compliance for key console features such as reliability growth, portability, usability, algorithms, motor control, and connectivity.
• Establish and deploy a Product Reliability Program, including accelerated life testing, reliability modeling, growth curves, statistical demonstration, and test‑to‑failure strategies.
• Drive improvement of system‑level design documentation (architecture, interfaces, functional specifications) with systems engineering to ensure clear verification responsibility, testability, and traceability.
• Ensure excellence in design controls (design inputs/outputs, reviews, V&V, design transfer).
• Lead and integrate risk‑management activities (hazard analysis, FMEA, risk controls).
• Utilize field and verification data to drive product quality improvement initiatives through CAPA, root‑cause analysis, and correction verification.
• Partner with Engineering and Quality to align on requirements, design intent, and verification strategies; provide guidance on testing scenarios and measurable, verifiable requirements.
• Apply advanced statistical methods to support sampling, reliability demonstration, acceptance decisions, and data‑driven NPD and post‑market activities.
• Act as a change agent, fostering cross‑functional alignment and best‑practice adoption; provide hands‑on technical guidance to develop fault‑tolerant, robust system designs.
• Mentor design quality and R&D engineering teams; serve as an escalation point for high‑risk technical quality issues.
• Communicate recommendations and mitigations to program and senior leadership using quantitative metrics.

• 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, focused on electromechanical and software products.
• Extensive experience supporting NPD programs with design controls, regulatory compliance, system engineering, risk management, and reliability engineering.
• Strong expertise in advanced statistical methods and sampling strategies for design verification and validation.
• Demonstrated experience leading complex FMEA activities and integrating human‑factors and usability into product development.
• Proficiency with ISO 14971, IEC 60601, IEC 62366, ISO 13485, and related regulatory frameworks.

• Proven technical leader and change agent driving high‑impact initiatives across engineering, quality, and regulatory groups.
• Exceptional communicator capable of translating technical risk and statistical analysis into clear program‑level decisions.
• Detail‑oriented, systems‑level thinker with a track record of improving product quality, reliability, and design rigor.
• Comfortable working in fast‑paced NPD environments; capable of influencing product roadmap priorities based on quality and reliability trade‑offs.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law.