Senior Verification Specialist
2 weeks ago
Job Summary
We are seeking a seasoned engineer to lead design verification and validation efforts in support of product lifecycle management and new product development. This key role involves developing and optimizing physical test methods, collaborating with cross-functional teams, and ensuring compliance with quality systems and regulatory requirements.
Responsibilities- Develop and refine physical test methods and fixtures to support design verification and commercialization of medical device products.
- Create engineering technical reports, test method work instructions, and procedures to facilitate efficient testing and validation processes.
- Lead and execute test method validation, design verification, and test method transfer activities to ensure product design integrity and regulatory compliance.
- Author design verification protocols that satisfy system requirements and Quality System standards.
- Manage and track product configurations through design verification and validation.
- Conduct hands-on and simulated testing for design verification and test method developments.
- Evaluate functional and performance characteristics of products to ensure conformance to specifications.
- Collaborate with external partners, operations, quality, and IT groups to achieve design verification and validation objectives.
- Support data review, analysis, and interpretation, identifying and reporting out-of-specification results, and contributing to investigations and Root Cause Analysis.
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