To strengthen our team in Switzerland we are looking for a Medical Device Project Manager. As an Altran Consultant you play a key role in the research and the development of new class I II or III medical devices (instrument, apparatus, implant, in vitro reagent).
You will :
Coordinate and Manage R&D activities.
Design and develop Medical Devices.
Be responsible for Product Safety.
Specify and perform acceptance tests (performance, statistical quality, verification, validation) in collaboration with internal laboratories (design verification, design control).
Communicate with and manage suppliers.
Ensure compliance to quality standards and regulatory requirements (FDA, CE Marking, ISO 13485).
Provide Technical Documentation and build up Design History File of the products.
Your Profile : Education level :
Education level :
Master or Engineering Degree in Mechanical / Bio-Medical / Embedded System Engineering (EPFL, ETH, HES or equivalent) with emphasis on Medical Device development.
Minimum 5 to 7 years of program / project management with close customer or partner relationship in the medical device industry.
Proven experience in leading project development phase until the market launch of a medical device at high volume.
Proven experience in leading feasibility stage of a complex medical device.
Relevant related technical experience or background in the medical devices regulated industry (e.g. ISO13’485; CFR21 part 11, IEC62304, others).
Ability to manage financial aspects of a project or program.
Capacity to follow V&V cycle product development.
Languages : French as well as English.
Ready to join?
We offer in Switzerland an exciting tailored career path for your professional and personal development within an international company.
You will be accompanied from the beginning with specific coaching and mentoring programs and intensive training on innovation and management in a fast-
moving and results driven environment.
We are looking forward to meeting you very soon at Altran Switzerland.