Senior R&D Manager

Posted 27 August 2021
Negotiable
Location
Job type Permanent
DisciplineLife Sciences
ReferenceBBBH469990_1630061982

Job description


TriCares is a medical device start-up organisation with a vision to bring to market heart valve replacement systems and help more than 12.7 million patients suffering from severe heart valve diseases by minimising the need for open heart surgery. Following the successful completion of a €22 million investment TriCares is now looking to expand their operations facility in Munich and continue to develop high quality and innovative medical devices to address the global market.

The Role
TriCares Senior R&D Manager will have direct responsibilities on sterile packaging development from concept to final design, including verification and validation.
Also, you will have an active role in transferring existing machined handle into commercial moulded handle, including usability, verification and validation.
This is a senior level role that will best suit an experience professional looking for a new challenge with experience or knowledge of medical devices, who is able to manage several projects and lead a team.

Key Responsibilities
External partners:

  • Manage several projects with external vendors/suppliers



Sterile packaging

  • Manage and develop sterile packaging (from concept to final design)
  • Verification and Validation of packaging



Production:

  • Convert existing machined catheter handles into commercial moulded handles
  • Verification, validation and check usability of moulds



Essential Requirements

  • Bachelor's degree in Engineering or similar
  • Medical device experience Class II/III (minimum 5 years)
  • Familiar with medical devices development requirements (eg.IEC 62366-1)
  • Understanding Design Control methodology
  • Packing development and moulding Knowledge
  • Project management Knowledge
  • Familiar with ISO 11607 (preferably)
  • IT: Solid works and 3d printing knowledge + MS Office
  • Fluency in English (mandatory) + German (preferably)
  • Familiar in clinical environment (preferably)
  • A collaborative and pro-active mindset
  • Availability to travel

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