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The role also benefits from the ability to identify new product opportunities for innovation, cost savings, and other improvements. Thorough knowledge of assigned products and cross-functional collaboration are the keys to success in this role.
Key Responsibilities:
- Own released devices within heart portfolio during their life cycle
- Develop product documentation in compliance with regulatory requirements and internal quality system
- Manage technical documentation after development project completion
- Transfer of design from R&D to production establishment
- Initiate and implement product design changes
- Support with CAPAs non-conformities and complaints
- Drive, coordinate and complete the post market surveillance
- Provide technical product expertise to Commercial, Operations and suppliers
- Participate in projects to improve existing and develop future products
Essential for the role:
- Bachelor’s Degree in mechanical, chemistry, biology, engineering, or related field
- Extensive experience in Technical documentation
- Understanding/experience with FDA, ISO and/ or MDR regulations
- Experience from cross-functional projects
- Excellent interpersonal skills; team-oriented relationship builder as well as ability work independently
- Customer focused and performance-driven
- Strong project management skills
- Process oriented and organized
- Willingness to learn
Key Skills
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