Senior Principal Quality Engineer – Design Quality & Systems Excellence

Johnson & Johnson is a global leader in healthcare innovation, dedicated to preventing, treating, and curing complex diseases and advancing personalized solutions.

Senior Principal Quality Engineer – Design Quality & Systems Excellence (Danvers, MA). Lead technical quality initiatives across complex electro‑mechanical, software‑driven medical devices, ensuring robust product design through system engineering principles, design controls, risk management, and reliability engineering.

• Lead design quality strategy across NPD programs, ensuring robust, reliable, and compliant products.
• Serve as primary quality partner, embedding quality‑by‑design principles and ensuring design control compliance for key Impella console features.
• Establish and execute a Product Reliability Program, including accelerated life testing, reliability modeling, and life‑testing strategies.
• Drive improvement of system‑level design documentation, architecture, interfaces, and functional specifications.
• Ensure excellence in design controls, conduct reviews, V&V, and design transfer activities.
• Lead and integrate risk management activities, including hazard analysis, FMEA, and risk controls.
• Use field data, CAPA, and root‑cause analysis to drive product quality improvement initiatives.
• Lead cross‑functional failure investigations, ensuring timely corrective actions and verification of effectiveness.
• Collaborate with engineering and quality teams on requirements, design intent, and verification strategies.
• Provide technical guidance on testing scenarios and influence requirements definition for measurable and verifiable features.
• Apply advanced statistical methods for sampling, reliability demonstration, and data‑driven decisions.
• Act as a change agent to drive cross‑functional alignment and best‑practice adoption.
• Mentor design quality and R&D engineers on system engineering principles and techniques.

• ISO
  14971 – Lead risk management for medical devices, integrating hazard analysis and risk control with design inputs.
• IEC
  60601 – Translate safety and performance requirements into design inputs and verification strategies.
• FMEA – Lead cross‑functional FMEA activities for complex systems, linking outputs to design improvements.
• IEC
  62366 – Integrate human‑factor engineering, perform risk analysis, and translate usability findings into requirements.
• ISO
  13485 – Deep knowledge of design controls, quality systems, audit readiness, and regulatory inspections.
• Advanced Statistics – Design risk‑based sampling, reliability demonstration, and hypothesis testing for regulatory and product decisions.

• Bachelor’s or Master’s degree in Electrical, Mechanical, Biomedical, or related engineering field.
• 12–15+ years of experience in medical device development and quality engineering.
• Extensive background supporting NPD programs for electro‑mechanical/embedded systems, including console products and motor control, sensors/algorithms, portability, usability, and connectivity.
• Expertise in design controls, regulatory compliance, system engineering, risk management, reliability engineering, and advanced statistical methods.

• Proven technical leader and change agent with a track record of high‑impact initiatives.
• Ability to influence across Engineering, Quality, and Regulatory teams.
• Detail‑oriented systems‑level thinker with a history of improving product quality, reliability, and design rigor.
• Excellent communicator, able to translate technical risk and statistical results into clear program‑level decisions.
• Comfortable in fast‑paced NPD environments, 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.

Pay range: $ – $.