Senior Medical Device V&V Engineer – Electrical & EMI/EMC Compliance | Contract | Indianola, PA (Onsite)

Senior Medical Device V&V Engineer – Electrical & EMI/EMC Compliance | Contract | Indianola, PA (Onsite)Senior Medical Device V&V Engineer – Electrical & EMI/EMC ComplianceLocation: Indianola, PA
Job Type: Contract
Experience: 8–12 Years
Work Arrangement: Onsite – Product Testing Lab / Client LocationJob SummaryWe are seeking an experienced Senior Verification & Validation (V&V) Engineer with strong expertise in medical device hardware testing, mechatronic product validation, electrical safety, and EMI/EMC compliance testing.The ideal candidate will have hands-on experience planning and executing verification and validation activities for medical devices and electromechanical products, ensuring compliance with applicable industry standards, including IEC 60601, UL, and CE requirements.This role requires practical experience with hardware testing, compliance certification, environmental testing, troubleshooting, and coordination with external accredited testing laboratories.Key Responsibilities1. Testing & Validation

• Plan and execute functional testing and performance evaluations on hardware prototypes and medical device products.
• Identify, troubleshoot, and resolve hardware functionality, reliability, and compatibility issues.
• Collaborate with software and hardware engineering teams to validate hardware-software integration.
• Document test procedures, results, observations, and recommendations to improve product performance and reliability.

2. Compliance Testing & Certification

• Plan and execute EMI/EMC, electrical safety, and environmental compliance testing in accordance with applicable UL, CE, and IEC 60601 standards.
• Coordinate and support radiopharmaceutical (RP) testing activities.
• Execute test protocols in accordance with applicable regulatory and industry standards.
• Support package testing and environmental testing activities.
• Coordinate with external accredited laboratories for pre-compliance and formal certification testing.
• Prepare test setups, including grounding, shielding, and wiring configurations, for accurate EMI/EMC measurements.
• Participate in and witness formal EMI/EMC testing.
• Analyze test failures and non-compliance issues, perform root cause analysis, and provide actionable recommendations to engineering teams.
• Review applicable regulatory standards and ensure test methodologies align with certification requirements.
• Prepare and maintain detailed test reports, compliance records, and certification documentation.

Required Qualifications

• Bachelor's degree in Electrical Engineering, Electronics Engineering, Mechanical Engineering, or a related technical discipline.
• 8–12 years of experience in Verification & Validation, hardware testing, or product validation.
• Hands-on experience with mechatronic product verification and validation.
• Practical knowledge of medical device compliance and certification testing.
• Experience with EMI/EMC testing, electrical safety, and environmental testing.
• Knowledge of IEC 60601, UL, and CE standards.
• Experience preparing test setups, executing test protocols, analyzing failures, and documenting test results.
• Ability to work hands-on in product testing laboratories and at client locations.
• Strong troubleshooting, analytical, documentation, and cross-functional collaboration skills.

Preferred Experience

• Experience working with medical equipment or electromechanical products.
• Experience coordinating with external accredited testing and certification laboratories.
• Familiarity with pre-compliance testing and formal certification processes.
• Experience with package and environmental testing.
• Knowledge of grounding, shielding, wiring configurations, and EMC measurement techniques.