Technical Product Manager

XVIVO is a growing international medical technology company focused on developing optimized solutions for organ, tissue and cell preservation and perfusion in connection with transplantation. We are now recruiting for our R&D team in Gothenburg a Technical Product Manager (TPM).

The culture of XVIVO is the culture of a small company with ambition to grow, based on the foundation of a common belief that patient safety is key for our success. Our vision is that nobody should have to die waiting for an organ. We strongly believe in the fact that nothing is impossible and thrive to get the job done. We are, no matter which position or work description, always focused to help our customers.  Working at XVIVO is more than a job – it is an opportunity to change the world for transplant patients waiting for a new organ. This position offers an opportunity for the right candidate to be part of a great team and join us on our exciting growth journey!

As a Technical Product Manager, you are the technical expert of the product working closely with Marketing and Operations.  The TPM is the main technical contact towards the suppliers. At XVIVO the TPM is also involved in the development of the solutions.  The role also benefits from the ability to identify new product opportunities for innovation, cost saves and other improvements. Thorough knowledge of assigned products and cross-functional collaboration are the keys to success in this role.

Responsibilities in detail:

• Own released products within the 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.
• Plan, perform, document, and maintain risk management activities.
• Support with CAPAs, non-conformities, complaints.
• Drive, coordinate and compile the Post Market Surveillance.
• Provide technical product expertise.
• Participate in projects to develop existing and future products ranging from translating customer and business needs into product specifications.

 Qualifications

• Extensive experience from Technical documentation.
• Experience from cross-functional projects.
• Knowledge about ISO13485 and other relevant regulatory requirements for medical devices or pharmaceuticals.
• Good understanding of QA/RA requirements.
• Working with product development in the Life Science industry, preferably medical devices.
• Experience from transplantation and/or medical fluids/solutions class III/pharmaceuticals would be considered an advantage.

As a person you have a strong customer focus, and you have a personal drive. You take initiative and you have a non-prestigious attitude. You enjoy working in cross-functional teams and you communicate effectively.

We look forward to your application!

 Application and contact 
This recruitment is managed by our recruitment partner, Moveup Consulting AB. To apply, please send your CV and a cover letter to katarina.wanderydz@moveup.se

If you have questions regarding XVIVO Perfusion AB or this open position, please contact Katarina Wanderydz at +46 (0)738 – 55 44 51.

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