Senior Product Verification Engineer - Medical Device

Job Title: Senior Product Verification Engineer - Medical Device

Location: Pennsylvania, PA Onsite

Duration: 6+ Months

Employment Type: W2 Contract

Rate: $50 - $55/hr W2

Experience: 5+ Years

Position Overview:

We are seeking a Senior Product Verification Engineer to support Design Verification, Test Method Validation (TMV), and product verification activities within a regulated medical device environment.

The ideal candidate will have strong hands-on experience with Design Verification, Test Method Validation, verification protocols and reports, medical device design controls, risk management, and single-use sterile medical devices. The engineer will collaborate with R&D, Quality, Regulatory, and Manufacturing teams throughout the medical device product development lifecycle.

Key Responsibilities:

• Develop and execute Design Verification (DV) plans, protocols, and reports
• Develop verification strategies, test methods, acceptance criteria, and sampling plans
• Perform Test Method Validation (TMV) to establish accurate, repeatable, and reproducible test methods
• Execute verification testing for single-use sterile medical devices
• Analyze verification and validation test data and document results
• Investigate test failures and deviations and support root-cause analysis
• Establish and maintain traceability between design inputs, product requirements, risk analysis, and verification testing
• Prepare technical documentation supporting the Design History File (DHF) and applicable regulatory submissions
• Support medical device design control activities throughout the product development lifecycle
• Apply risk management principles to verification and validation activities
• Collaborate with R&D, Quality, Regulatory, Manufacturing, and other cross-functional teams
• Support development and implementation of verification protocols, reports, and associated technical documentation
• Ensure verification and validation activities are conducted in accordance with applicable procedures, quality requirements, and industry standards
• Support compliance with applicable FDA requirements, ISO 13485, ISO 14971, and relevant medical device standards

Required / Preferred Qualifications:

• Bachelor's degree in Engineering, Biomedical Engineering, or a related technical field preferred
• 5+ years of medical device verification and/or validation experience
• Strong hands-on experience with Design Verification (DV)
• Proven experience with Test Method Validation (TMV)
• Direct experience with single-use sterile medical devices
• Strong understanding of medical device design controls
• Experience with medical device risk management and verification traceability
• Experience developing and executing verification protocols and reports
• Experience analyzing test data, troubleshooting failures, and supporting root-cause investigations
• Strong technical writing and documentation skills
• Familiarity with DHF and regulatory documentation
• Knowledge of applicable FDA requirements, ISO 13485, ISO 14971, and relevant medical device standards
• Strong analytical, problem-solving, and cross-functional communication skills