Senior Test Engineer, Medical
TÜV Rheinland North America
full-time
Posted on:
Location Type: Office
Location: Pleasanton • California • United States
Visit company websiteExplore more
Salary
💰 $105,000 - $115,000 per year
Job Level
About the role
- Complete all aspects of regulatory compliance testing and reporting of medical device products
- Develop and implement test procedures for testing of components, subsystems, and medical device products
- Act as lead engineer on complex projects and plan schedules
- Conduct applicable testing to ensure products meet regulatory compliance requirements
- Document test results and perform analysis of test data
Requirements
- Bachelor's Degree in a technical discipline or equivalent education and/or experience in medical product safety testing
- 7 years minimum test experience and evaluating medical device products in accordance with product regulatory standards
- Significant experience with IEC 60601 standards
- Knowledge of ISO 14971 Risk Management Process, IEC 60601-1-6 and IEC 62366 Usability Engineering Process
- Ability to train other test engineers and test technicians
- Knowledge of CB requirements such as OD-2044, OD-2048, OD-5010, etc.
Benefits
- Competitive pay
- Multiple health insurance plan options
- 401(k) with up to 6% company match
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory compliance testingtest procedures developmenttest data analysismedical device testingIEC 60601 standardsISO 14971 Risk Management ProcessIEC 60601-1-6IEC 62366 Usability Engineering ProcessCB requirementsmedical product safety testing
Soft Skills
leadershipproject planningtrainingcommunication