Senior Reliability Engineer
Core
Analyze product performance data, support risk assessments, and investigate quality issues to improve reliability of implantable medical devices like pacemakers and defibrillators.
Role type
Senior Reliability Engineer (Medical Devices)
Builds
Implantable cardiac rhythm management devices (pacemakers, defibrillators, leads)
Domain
Healthcare / Medical Devices / Regulatory Compliance
Required skills
Reliability engineering, Risk management (ISO 14971), Root cause analysis, Design verification and validation, Statistical data analysis, Electrical design debugging (RF), Regulatory standards knowledge (21 CFR 820, ISO 13485)
Preferred skills
CRM product knowledge, Clinical field experience, Design change risk assessment
Technologies
Statistical tools, Reliability tools, Electrical design tools
Responsibilities
Analyze product performance data for post-market surveillance, Support risk analysis studies of designs and processes, Author or support preparation of risk assessments and technical reports, Support verification and validation of device system requirements, Conduct or support evaluation of finished product systems, Collaborate with cross-functional partners to investigate quality issues
Seniority
Senior, hands-on IC