Work SiteSwitzerland / | CHE - All Regions / Basel
Contract TypePermanent [Full-Time]
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.
Altran deploys its expertise particularly in:
Life Sciences (Pharma, Biotech, and Medical Devices),
Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking
Telecoms
Public sector
Your role
Leading the definition of product requirements for packaging, medical devices, delivery systems, e.g. drug/device combination products in which the device is generally already registered but sometimes to be developed
Provide primary packaging and device expertise in a broader cross-functional drug product development team
Supporting and coordinating the manufacturing of clinical material and the production scale up
Managing and monitoring Human Factors Engineering activities
Leading Risk management activities
Planning and monitoring of design verification activities (in-house)
Ensuring a high quality Design History file
Your profile
MSc degree in Packaging Science/Engineering
An ideal candidate would have a relevant degree in engineering and at least 7 years’ experience in leading device development technical teams in a similar area
Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation)
Development and writing of technical documentation of drug/device combination products and medical devices, including Design Control process and other applicable regulatory, QA and GMP aspects
Experience with Design Control, ISO1345, Primary Pharmaceutical Packaging Development, ideally for combination products is important.
