Staff Medical Product Quality & Reliability Engineer

What You'll Do

• Strategy & Leadership Develop and implement comprehensive V&V and reliability strategies for new and existing medical devices.
• Support definition and monitoring of 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.
• Technical Execution 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.
• Compliance & Governance Ensure adherence to global standards (ISO 13485, FDA QSR, ISO 14971, EU MDR, IEC 62304 for software).
• Support internal and external audits (FDA, Notified Body) and drive audit readiness and response activities.
• Support post-market surveillance and integrate reliability monitoring into CAPA processes.
• Collaboration & Mentorship 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.
• Required Skills and Qualifications 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 supporting 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.
• Certifications: Lean/Six Sigma highly desirable; ASQ CRE preferred.
• For positions requiring access to technical data, Analog Devices, Inc. may have to obtain export licensing approval from the U.S.
• Department of Commerce - Bureau of Industry and Security and/or the U.S.
• Department of State - Directorate of Defense Trade Controls.
• As such, applicants for this position – except US Citizens, US Permanent Residents, and protected individuals as defined by 8 U.S.C. 1324b(a)(3) – may have to go through an export licensing review process.
• We foster a culture where everyone has an opportunity to succeed regardless of their race, color, religion, age, ancestry, national origin, social or ethnic origin, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, parental status, disability, medical condition, genetic information, military or veteran status, union membership, and political affiliation, or any other legally protected group.
• EEO is the Law: Notice of Applicant Rights Under the Law .
• Job Req Type: Experienced Required Travel: Yes, 10% of the time Shift Type: 1st Shift/Days The expected wage range for a new hire into this position is $113,190 to $163,905.
• Actual wage offered may vary depending on work location , experience, education, training, external market data, internal pay equity, or other bona fide factors.
• This position qualifies for a discretionary performance-based bonus which is based on personal and company factors.
• This position includes medical, vision and dental coverage, 401k, paid vacation, holidays, and sick time , and other benefits.