Job Title: Verification & Validation (V&V) Engineer Medical Devices
Location: Indianola, PA (Onsite)
Engagement Type: Contract
Experience: 8 12 Years
Work Mode: Onsite Product Testing Lab / Client Location
Job Summary
We are seeking an experienced Verification & Validation (V&V) Engineer to support testing, compliance, and certification of medical device products. This role requires hands-on hardware validation, coordination with external certification labs, and close collaboration with hardware, software, and regulatory teams to ensure product performance, safety, and compliance with global medical device standards.
Key Responsibilities
< data-start="914" data-end="956">Verification & Validation Testing</>
Plan and execute functional, performance, and reliability testing on hardware prototypes and production units.
Perform hands-on troubleshooting of hardware-related issues affecting functionality, performance, and system compatibility.
Collaborate with software and firmware teams to validate hardware software integration.
Execute test protocols in accordance with industry and regulatory standards.
Document test procedures, results, defects, and corrective actions to improve product reliability and performance.
< data-start="1512" data-end="1552">Compliance & Regulatory Testing</>
Plan, support, and execute compliance testing including EMI/EMC, electrical safety, and environmental testing.
Ensure testing aligns with UL, CE, IEC 60601, and other applicable medical device standards.
Support radiopharmaceutical (RP) testing activities as required.
Provide support for package integrity and environmental qualification testing.
Prepare test setups including grounding, shielding, cabling, and wiring for accurate EMI/EMC measurements.
Witness EMI/EMC testing and support formal certification efforts.
< data-start="2130" data-end="2180">Certification & External Lab Coordination</>
Coordinate with external accredited laboratories for pre-compliance and formal certification testing.
Review applicable regulatory standards and ensure test methods meet certification requirements.
Analyze test failures and non-compliance issues, perform root cause analysis, and provide actionable feedback to design teams.
Support debugging and design remediation to achieve compliance.
< data-start="2602" data-end="2636">Documentation & Reporting</>
Prepare and maintain test reports, compliance documentation, and certification records.
Ensure all verification, validation, and compliance documentation meets regulatory and audit requirements.
Required Skills & Qualifications
Bachelor s degree in Electrical, Electronics, Mechanical Engineering, or equivalent.
8 12 years of hands-on experience in Verification & Validation (V&V) of mechatronic or medical device products.
Strong experience with medical device compliance and certification testing.
Solid understanding of IEC 60601, EMI/EMC, electrical safety, and environmental testing standards.
Experience working in product testing laboratories and onsite customer environments.
Strong analytical, troubleshooting, and documentation skills.
Ability to collaborate effectively with hardware, software, and regulatory teams.
Nice to Have
Experience supporting FDA-regulated or highly regulated product environments.
Prior interaction with third-party certification bodies and test labs.
Exposure to radiopharmaceutical or imaging-related medical devices.
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