Job Description
Job description: As a member of the Client's Acute Therapies Verification and Validation engineering team, you would be responsible for supporting product verification, validation, and compliance test activities on electrical and mechanical medical device components/systems. Your expertise will be applied to all levels of product development from component prototypes to final system design. This will include developing, executing, and validating test methods/creating associated documentation. Interface with/support different groups, e.g., R&D, Project Management, Quality, and manufacturing.
Responsibilities: - Under supervision, Develop/execute verification test methods, protocols, and reports for verification of requirements on components and systems.
- Drive quality into product development through analysis, test, and timely feedback of test results back to team.
- Under supervision, Design test cases to include test methodology, test setups, materials, equipment, procedure, and acceptance criteria based on requirement and standard.
- Execute functional testing of mechanical assemblies, electrical circuits, and systems.
- Support hardware team in product development, concept feasibility, pre compliance and change activities by developing test, collecting, and providing test data.
- Under supervision, design hardware and/or software tools and fixtures used to execute test methods and analyses data.
- Review, understand and characterize electrical/mechanical designs to develop test methods and ensure coverage of requirements.
- Read/understand medical compliance standards and requirements, evaluate risk, and develop test procedures to ensure requirements are met.
- Perform hands on test execution in the lab and at third party medical device test labs, communicate all defects/issues/failures during the test execution.
- Under supervision, develop and implement feasibility and characterization testing on designs.
- Analyze test data for conformance to pre-determined acceptance criteria and record clearly results in testing platforms like ALM.
- Collaborate with System team to better understand requirements and improve test effectiveness.
- Actively participate in improving existing testing scenarios and test cases.
- Maintain laboratory equipment and inventory levels for laboratory supplies
- Perform troubleshooting, hands on rework and calibration of electromechanical Systems.
Requirements: - Bachelor's degree in engineering with 3+ years of experience.
- Experience with system and component level electromechanical V&V testing, plans/procedures/reports, equipment, and test methods preferred.
- Demonstrated results in both Troubleshooting/resourcefulness; use own expertise/guidance from others to identify/resolve critical issues. Understanding/application of root cause analysis methods.
- Knowledge of electrical/mechanical engineering disciplines with ability to read, understand and analyze electrical schematics/ mechanical drawings
- Experience using electrical/mechanical lab equipment. e.g., oscilloscope, DMM, power supply, force/pressure gauge, caliper, thermometer, flow meter and scales.
- Takes a hands-on approach to testing, fault diagnosis and isolation.
- Experience creating detailed, clear, and complete documentation and records.
- Demonstrated experience collaboratively and effectively across disciplines/project teams.
- Comfortable/effective in a fast-paced environment, where small teams share a broad variety of duties.
- Experienced Verification & Validation Engineer specializing in electromechanical systems for medical devices.
- Skilled in test development, protocol/report writing, and ALM-based traceability.
- Proficient in troubleshooting and root cause analysis (5 Whys, Fishbone, FTA, FMEA).
- Designed custom LabVIEW scripts and 3D-printed fixtures for automated testing.
- Troubleshoot electrical/mechanical failures using DMM, oscilloscope, and gauges.
- Performed pre-compliance EMC screening on PCB subsystems, capturing radiated emissions and susceptibility data for early corrective action.
- Interprets electrical schematics and CAD models to ensure test coverage.
- Authored V&V documentation compliant with 21 CFR 820 and ISO 13485 standards.
- Collaborated with cross-functional teams including R&D, QA, and firmware groups.
- Performed pre-compliance EMC screening on PCB subsystems, capturing radiated emissions and susceptibility data for early corrective action.
- Focused on improving compliance, test coverage, and reusable test frameworks.
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