Minimum number of years of experience required5 years of experience and more
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Your role
Responsible for the whole product life cycle management in a regulated environment
Collaborate actively on the development of combination products and on design transfers
Authoring design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, usability (IEC62366), Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation (ISO14971)
Applying theoretical and practical engineering knowledge to establish robust technical product requirements
Lead dedicated team efforts, e.g. regulatory submissions preparation, root cause analysis etc.
Act as a project manager ensuring in-time delivery, budget management and quality.
Your profile
M.Sc. degree in engineering or related discipline
At least 5 years of experience in material sciences and development of drug delivery/combination products
Good understanding industry standards and guidance within the area of combination products and medical devices
Very good knowledge of Medical device regulations incl. FDA 21CFR 820, EU MDD/MDR, ISO 13485, ISO 14971, IEC 62366, CE marking, 510 (k), 21 CFR 4 for combination products
Technical knowledge to support the development of electronic smart/connected medical devices
Project / program management skills of complex projects with multiple suppliers and stakeholders
