Verification & Validation (V&V) Engineer Medical Devices | Contract | Indianola, PA (Onsite)

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.