Principal Reliability Engineer
Core
Provide technical leadership for post-market quality, risk management, and reliability of commercial medical device portfolios to ensure patient safety and product performance.
Role type
Principal Reliability Engineer (Post-Market Quality)
Builds
Commercial medical device portfolio reliability and safety compliance
Domain
Medical Devices / Healthcare Technology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Risk management (ISO 14971), Health Risk Assessments, Post-Market Surveillance, Root Cause Analysis, Failure Analysis, Design Control (FMEA, V&V), Statistical Data Analysis, Technical Writing
Preferred skills
Medical device industry experience, Cross-functional leadership, Coaching/Mentoring
Technologies
ISO 14971, FMEA, V&V protocols
Responsibilities
Lead Health Risk Assessments and recommend Field Corrective Actions; Monitor product performance and analyze reliability data; Investigate product failures and complaints; Assess design changes and approve test validations; Collaborate on corrective and preventive actions; Provide technical support to customers; Mentor junior engineers
Seniority
Principal, hands-on IC with strategic leadership