Software as Medical Device (SaMD) Expert

Capgemini Engineering

LausannePermanent contract
Il y a 7 jours

L'entreprise : Capgemini Engineering

- A permanent contract with the leader in innovation and high-tech engineering consulting


For our client, a global healthcare company, we are looking for Software as Medical Device(SaMD) Expert

In order to support the expanding development of "Software as a Medical Device" (SaMD), we are looking for a Lead Expert App Development. The successful candidate is a recognized expert for development and maintenance of safety critical mobile and/or web applications and will take over the technical leadership for the software development part for projects classified as SaMD within the Team. The role includes early phase development activities, the management and monitoring of software development at our external partners, and the commercialization and maintenance of overall life cycle management as legal manufacturer. In addition to outstanding project management and interpersonal skills, a strong background in software development and lifecycle management, as well as the use and implementation of platform technologies, is crucial for this role. The successful candidate will play a critical role in the support and sustainable expansion of the SaMD area.

Description du poste

Tasks and responsibilities will typically include:

- 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:
- Leading and/or supporting cross functional project teams during development, review and
submission of regulatory dossiers

Description du profil

Requirements:
=> 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 5 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
=> Fluency in English language French is a plus
=>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

Ready to join?

Capgemini Engineering will be on the forefront in creating an optimal work-life balance, more autonomy in where and how our people work and to embrace the learnings we have experienced from wider-scale remote working. For you, this may mean less time in the office than usual with some time working from home, whereas other roles and engagements will continue to be more location-dependent or office-based. Together with your manager, you will agree an approach which works for you, your team and our business.

In order to deploy this novel way of working, we have introduced our New Normal policy which includes:

  • 30% to 70% remote work in agreement with your line manager and client needs
  • Trust-based managerial culture
  • Team rituals and get togethers
  • Options to order ergonomically proven Equipment (monitor & chair) for your home office premises.
Référence : 20902