Lead Expert App Development
Altran
Basel, CH
vor 2 Tg.

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 with over 250'000 consultants around the world and a Group revenue (Altran / CapGemini) of EUR.
  • 17 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D)

  • In Switzerland, Altran employs more than 400 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
  • Your role

  • Technical leadership for the software development of mobile and / or web applications classified as SaMD
  • Providing software / systems life cycle expertise within a broader cross functional drug product development team
  • Supporting the standardization of the entire SaMD life cycle management process in order to utilize cross product synergies
  • Leading the collaboration with external development partners : Support supplier selection, auditing and approval Elaboration of development plans and contracts for upcoming projects Monitor work progress according to plan Monitor, support and challenge technical development and deliverables as well as change, test and release strategies Support the deployment and implementation of a sustainable Product Life Cycle process in close collaboration with external and internal partners and stakeholders
  • Leading and / or supporting cross functional project teams during development, review and submission of regulatory dossiers
  • Leading risk management activities
  • Planning and monitoring of design verification activities
  • Leading and authoring technical documentation
  • Ensuring a high quality Design History File
  • Supporting the improvement of the SaMD QMS.
  • Your profile

  • MSc / MA in computer science or relevant field and excellent understanding of the current Agile development methods and technologies
  • Autonomous and independent working style with at least 7 years of experience as technical project management of projects with safety critical applications in a regulated environment
  • Experience in designing innovative software and systems architectures
  • Excellent understanding of software design and programming principles as well as in overall verification strategies, including test set up and test automation
  • Considerable experience of managing external suppliers
  • Understanding of medical device regulations (FDA 21CFR 820, FDA 21CFR Part 4, EU Medical Device Directive, EU Medical Device Regulation), including those related to medical software (IEC 62304)
  • Development and writing of technical documentation of drug / device combination products and medical devices, including the design control process and other applicable regulatory, QA and GMP aspects
  • Fluency in English language
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