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Analog Devices · 2 weeks ago

Staff Medical Product Quality & Reliability Engineer

Wilmington, MA

Full-time

Onsite

Senior Level, Lead/Staff

$106K/yr - $160K/yr

5+ years exp

Analog Devices, Inc. is a global semiconductor leader that bridges the physical and digital worlds. They are seeking a Staff Medical Product Quality and Reliability Engineer to provide strategic leadership in developing and improving verification and reliability strategies for medical devices, ensuring compliance with global regulations and driving quality culture.

DSPElectronicsLightingSemiconductor

No H1B

U.S. Citizen Only

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

V&V strategiesRegulatory complianceReliability analysisRisk managementLean/Six SigmaAutomated test systemsCommunication skillsLeadership skillsCross-functional collaboration