Work SiteSwitzerland / | CHE - All Regions / Basel
Contract TypePermanent [Full-Time]
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.
Altran deploys its expertise particularly in:
Life Sciences (Pharma, Biotech, and Medical Devices),
Industry, Aerospace, Automotive, Energy, Railways
Your role
You will take part in all software engineering activities from analysis, design and planning through implementation and testing to maintenance
You are expected to build up a deep understanding of the domain, the workflow and the applications
You take a great interest in applying your abstraction skills to understand, model and design sustainable software solutions
Manage process to align stakeholders on DAS/ERPS product definition (including requirements, intended use, classification, target population, realization process, risk management), governance and design control approach
Drive vendor selection, contracting, onboarding (QMS & IGM audits, quality agreement, Service level agreement etc.) and ongoing management
Support development of a project plan for DAS/ERPS together with vendor and stakeholders in line with medical device requirements (ISO 13485) and internal SOPs
Drive creation and storage of key DAS/ERPS documents by stakeholders to ensure compliance Requirements for the Propeller Add-on System
Provides support to GPT Project Lead on vendor management / alignment with DAS development / alignment with stakeholders Timing
Your profile
M.Sc. in Computer Science / Engineering or equivalent academic degree
At least 5 year of experience in medical device industry, experience in managing SaMD projects
Understanding of Software as medical device (SaMD) and medical device regulations incl. FDA 21CFR 820, EU Medical Device Regulation, ISO13485
Directive MDD and AIMD, and associated harmonized standard, ISO 13485, EN60601, EN14971, EN62304
Significant experience in project / program management of complex projects with multiple suppliers and stakeholders
General understanding of Human Factors Engineering and Risk management
Excellent communication and technical writing skills for medical device documentation, including Design Control process and other applicable regulatory, QA and GMP aspects
