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