XVIVO is in a rapid growth phase, including both geographical expansion and the development and launch of new products and supporting processes. We are now looking to strengthen our R&D team in Groningen, the Netherlands, with a Technical Product Manager (TPM).
As a TPM, you are the technical expert of the product working closely with Marketing, Operations and Quality. The TPM is responsible for the technical documentation and is the main technical contact towards the suppliers and internally. A large part of the work consists of maintaining and updating the product technical file documentation.
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 the abdominal 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
· Bachelor’s Degree in 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
None
The first global all organ company
Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs – so transplant teams around the world can save more lives. Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine.
We are committed to providing our customers with solutions and systems that can improve the transplant process outcome, facilitate the work for the transplant team, and enhance the long-term outcomes and quality of life of the transplant recipient.
We believe nobody should die waiting for a new organ.
