Software as Medical Device (m/f)
ALTRAN
Basel
vor 14 Tg.

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,
  • Financial Services : P&C Insurance, Health Insurance, Reinsurance, Banking
  • Public sector
  • Job Title Software as Medical Device (m / f)
  • Vacancy Reference Number 14138
  • Work Site Switzerland / CHE - All Regions /
  • Zürich
  • Contract Type Permanent Full-Time
  • Minimum number of years of experience required 5 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

  • Responsible for software engineering activities : requirements, design, usability (EN 62366), development, production, and product life cycle management (EN 62304), testing to maintenance (ISO 14764).
  • Responsible for the implementation of Disciplined Agile Delivery methodology (DAD) within the regulatory framework, aligned to the essential requirements for MDD 93 / 42 / EEC.
  • Manage process to align stakeholders on DAS / ERPS product definition (including requirements, intended use, classification, target population, realization process, risk management according ISO 14971, 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.
  • Your profile

  • M.Sc. in Computer Science or equivalent academic degree;
  • At least 7 to 10 years of experience in medical device industry;
  • Good knowledge of embedded software / hardware for Medical Devices;
  • experience in managing SaMD projects would be a plus;
  • Understanding of Software as medical device (SaMD) and medical device regulations incl. FDA 21CFR 820, EU Medical Device Regulation, ISO13485, ISO 14971, EN 62304,
  • EN 62366 ;
  • Understanding of Cloud Platform (SaaS, PaaS), Bluetooth connectivity;
  • 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;
  • Languages : English fluent, German is a plus
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