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),
Industry, Aerospace, Automotive, Energy, Railways
Your role
Provide human factors engineering expertise to project teams developing combination product drug delivery devices,
Taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered,
Collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and program management to inform and guide development of innovative Products and ensure that those products are safe and easy to use,
Conduct human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies,
Develop instructions for use and training materials for clinical trial and commercial purposes.
Your profile
Master degree in human Factors Engineering, Mechanical Engineering, Bioengineering, or related discipline,
5 years of experience in developing and documenting Human Factors activities for medical devices as required by regulation,
Ideally experience with combination products (medical device and drug product),
Specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission, risk management regulations, standards, and guidances for medical devices and combinations products,
Experience in project / program management,
Good understanding of the risk management activities,
