Analog Devices · 1 month ago
Staff Medical Product Quality & Reliability Engineer
US, MA, Wilmington
Full-time
Onsite
Senior Level, Lead/Staff
$106K/yr - $160K/yr
5+ years expAnalog Devices, Inc. is a global semiconductor leader that bridges the physical and digital worlds. The Staff Medical Product Quality and Reliability Engineer will provide strategic leadership in developing and improving verification and reliability strategies for medical devices, ensuring compliance with global regulatory requirements and driving a culture of quality and reliability across the organization.
DSPElectronicsLightingSemiconductor
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
Qualification
Required
Bachelor's degree in Engineering, Life Sciences, or related field
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
Preferred
Master's degree in Engineering, Life Sciences, or related field
Lean/Six Sigma certification
ASQ CRE certification
Benefits
Medical, vision and dental coverage
401k
Paid vacation
Holidays
Sick time
Discretionary performance-based bonus
Company
Analog Devices
Analog Devices (NYSE: ADI) defines innovation and excellence in signal processing. ADI's analog, mixed-signal, and digital signal
10001+ employees
H1B Sponsorship
Analog Devices has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (307)
2024 (145)
2023 (180)
2022 (148)
2021 (139)
2020 (166)
Funding
Current Stage
Public CompanyTotal Funding
$4.6MKey Investors
U.S. Department of Defense
2025-04-11Post Ipo Debt
2024-09-18Grant· $4.6M
2012-04-02IPO
Leadership Team
Vincent Roche
Chief Executive Officer and Chair of the Board of Directors
John Hassett
SVP Industrial & Consumer Group
Recent News
2026-01-06
2025-12-22
2025-12-15
Company data provided by crunchbase