Principal Reliability Engineer – Software Quality

Boston, Massachusetts, United States of America💼 Full-time💰 $140,600–$140,600🗓 2026-06-02 → 2026-07-30

Core

Ensure software quality for complex medical devices throughout the Product Development Process (PDP) lifecycle, identifying problems and coordinating cross-functional groups to meet quality objectives.

Role type

Principal Reliability Engineer (Software Quality)

Builds

Product software, manufacturing software, quality system software, and software technologies for medical devices.

Domain

Medical Devices / Healthcare

Deliverable

Required skills

C, C++, C#, Python, SQL, Minitab, Software Failure Mode Effect Analysis (SFMEA), Software Fault Tree Analysis (SFTA), Software validation, Automation testing, V&V, FDA 21 CFR Part 11, FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304, AAMI TIR45

Technologies

C, C++, C#, Python, SQL, Minitab

Responsibilities

Coordinate cross-functional groups for software quality objectives; Navigate complex government and industry regulations; Define and implement software quality metrics; Review, analyze, and disposition software defects and problem reports; Coordinate software validation processes including cybersecurity and design controls; Develop test methods and perform automation testing and verification.

Seniority

Principal, hands-on IC

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