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Job Description
Job Summary: Lead design assurance for Structural Heart devices, ensuring performance and safety throughout the product lifecycle, and collaborating with cross-functional teams to drive innovation and compliance.
- Participate in design process to ensure performance and safety of Structural Heart devices.
- Lead strategies for test method validations, design verification, and shelf-life protocols/reports.
- Maintain expert knowledge of regulatory compliance requirements for product design, development, transfer, and commercialization.
- Liaise with departments to build collaborative partnerships and provide quality input into new product development and process improvements.
- Support cross-functional teams to design protocols for new products/product changes.
Requirements:
- Bachelor's degree in a relevant technical discipline (e.g., Engineering, Science) and 4+ years of relevant experience.
- Dynamic team player and leader with excellent communication and influence skills.
- Competent level within Medical Device product design.
- Fluent in English (both writing and speaking).
Work Environment: Day shift role with flexibility to travel.