What are the responsibilities and job description for the Medical Device Validation Specialist position at Sentec?
Job Description
The Verification & Validation Engineer is responsible for ensuring medical devices meet design requirements by developing and executing tests to verify product functionality and performance. This role involves collaborating with cross-functional teams to ensure compliance with medical device quality and regulatory standards.
Essential Duties and Responsibilities:
- Develop and execute verification and validation (V&V) plans, protocols, and procedures for respiratory therapy medical devices.
- Collaborate with product development teams to review design inputs and outputs and ensure all V&V activities and outcomes are correctly traced to product requirements.
- Execute performance, system, and product testing to ensure design inputs meet device requirements and user needs.
- Work closely with design and quality teams to resolve any nonconformances identified during V&V activities.
- Prepare, and maintain V&V documentation, including test protocols, test results, and validation summaries, ensuring compliance with QMS standards.
