Sr Engineer (Medical Device Reliability)
Core
Plans, designs, executes, and analyzes reliability test regimens to predict the reliability of new medical device hardware and software products.
Role type
Senior individual contributor reliability engineer (medical device hardware)
Builds
Reliability test protocols, fixtures, and documentation for medical device hardware
Domain
Medical device hardware development and reliability engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Reliability testing and test design, electromechanical assembly analysis, data analysis, root cause analysis, test protocol development, fixture fabrication, regulatory compliance documentation, SQL, Excel/Access data manipulation, troubleshooting multiple technologies
Preferred skills
PLM database management, OSHA 29CFR 1910.1030 regulations knowledge
Technologies
Excel, Jira, SQL, PLM, QALT (Quantitative Accelerated Life Testing), Reliability Life Testing
Responsibilities
Develop and execute written test protocols (QALT, Reliability Life Testing), maintain reliability test equipment, assist in root cause analysis of field returns, organize and archive test records, design and fabricate test fixtures, prepare compliance documentation for FDA requirements
Seniority
Senior, hands-on IC
