Staff Medical Product Quality & Reliability Engineer

Analog Devices • Wilmington, MA

4d

About The Position

About Analog Devices Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world. With revenue of more than $9 billion in FY24 and approximately 24,000 people globally, ADI ensures today's innovators stay Ahead of What's Possible™. Learn more at www.analog.com and on LinkedIn and Twitter (X) . Job Summary The Staff Medical Product Quality and Reliability Engineer provides strategic leadership in developing, implementing, and continuously improving verification, validation (V&V), and reliability strategies for medical devices. This role ensures compliance with global regulatory requirements, drives V&V maturity, and integrates reliability engineering throughout the product lifecycle. The Staff Engineer leads cross-functional initiatives, mentors peers, and influences quality culture and regulatory readiness globally.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, or related field (Master’s preferred).
• 5+ years of experience in V&V and reliability within the medical device industry.
• Expert knowledge of global regulatory requirements (FDA QSR, ISO 13485, ISO 14971, EU MDR, IEC 62304).
• Strong proficiency in reliability tools, statistical methods, and quality systems (Six Sigma, eQMS).
• Demonstrated success in leading audits and regulatory inspections.
• Experience with risk management, post-market surveillance, and CAPA integration.
• Experience with digital tools for simulation, model-based systems engineering, and automated test systems.
• Exceptional communication, leadership, and cross-functional collaboration skills.

Nice To Haves

• Certifications: Lean/Six Sigma highly desirable; ASQ CRE preferred.

Responsibilities

• Develop and implement comprehensive V&V and reliability strategies for new and existing medical devices.
• Define and monitor V&V and reliability KPIs (e.g., MTBF, defect escape rates) to ensure performance targets are met.
• Provide technical leadership for regulatory submissions (FDA 510(k), PMA, EU MDR) and global compliance.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory teams to define product V&V and reliability plans.
• Conduct advanced reliability analyses (FMEA, Weibull, life data analysis, accelerated life testing, reliability growth modeling).
• Develop and validate test methods for V&V and reliability, including automated and model-based approaches.
• Support Design for Reliability (DfR) initiatives and integrate predictive analytics for reliability trends.
• Ensure adherence to global standards (ISO 13485, FDA QSR, ISO 14971, EU MDR, IEC 62304 for software).
• Lead internal and external audits (FDA, Notified Body) and drive audit readiness and response activities.
• Oversee post-market surveillance and integrate reliability monitoring into CAPA processes.
• Partner with suppliers to ensure component and system-level V&V and reliability requirements.
• Mentor engineers and cross-functional teams on quality principles, regulatory expectations, and continuous improvement.
• Influence change management and foster a culture of quality and reliability excellence.

Benefits

• medical, vision and dental coverage
• 401k
• paid vacation, holidays, and sick time
• discretionary performance-based bonus

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees