Principal Reliability Engineer
Core
Develop reliability strategies, plans, and testing for new medical device products to ensure they meet reliability requirements and regulatory compliance.
Role type
Principal Reliability Engineer (Medical Devices)
Builds
Medical device products for patient care
Domain
Healthcare technology / Medical Devices
Required skills
Reliability science, HALT/ALT testing, Design controls, Regulatory compliance (FDA/ISO), Root cause analysis, Reliability modeling, Cross-functional collaboration, Team leadership
Preferred skills
ASQ CRE certification, Six Sigma Green Belt, AAMI design control, ReliaSoft, LabVIEW, Sherlock, Risk management, Statistics
Technologies
ReliaSoft, LabVIEW, Sherlock
Responsibilities
Write reliability plans and identify activities during product development; Perform HALT, ALT, and discovery tests; Support test method validation and verification; Collaborate with R&D to design reliability tests and select materials; Conduct reliability predictions and data analysis; Provide post-market reliability support; Ensure compliance with FDA and ISO standards; Lead and mentor teams in reliability processes; Partner with software reliability teams.
Seniority
Principal, hands-on IC with mentorship