Description
You will support product verification, validation, and compliance testing for electrical and mechanical medical device components and systems.
Responsibilities
- Develop and execute verification test methods, protocols, and reports to validate requirements for components and systems.
- Design test cases including methodology, setups, materials, equipment, and acceptance criteria.
- Perform hands-on functional testing of mechanical assemblies, electrical circuits, and electromechanical systems in a lab environment.
- Analyze test data for conformance to acceptance criteria and record results within ALM.
- Design hardware or software tools and fixtures to execute test methods and automate data collection.
- Collaborate with R&D, Project Management, Quality, and manufacturing teams to provide timely feedback on test results.
Required Skills
- Engineering degree in Electromechanical, Biomedical, Electrical, or Mechanical Engineering.
- Experience with electromechanical devices, including motors, pumps, model panels, and circuit cards.
- Hands-on lab experience using oscilloscopes, DMM, and power supplies.
- Proficiency using mechanical gauges and calipers for precision measurement.
- Ability to draft technical documentation including test plans, procedures, and formal reports.
- Experience with V&V testing, traceability to requirements, and system validation.
- Knowledge of medical compliance standards and risk evaluation.
- Experience using ALM for data recording and management.
Preferred Skills
- Prior experience in electrical circuit design.
- Experience using design software to automate data collection.