Senior Software as Medical Device Engineer
F. Hoffmann-La Roche Gruppe
Basel, Basel-Stadt, Schweiz
vor 4 Tg.
source : JobLeads

The company is a pharm firm.

  • Device technical engineering expert for the development of mobile and / or web applications classified as SaMD in close collaboration with internal and external software / IT teams
  • Providing software / systems life cycle expertise within a broader cross-functional SaMD development team
  • Draft and / or review and / or approve design control documents (i.e. DHF documents) to support SaMD development deliverables such as specifications, protocols and reports, design verification, design validation, failure modes effects and analysis, risk management plans / reports
  • Closely collaborate with internal Quality and Regulatory Affairs representatives to ensure that SaMD solutions adhere to the applicable medical device, pharmaceutical and other applicable regulations
  • Drive engaging interactions with internal and external organizations to help advance the adoption of the developed solutions
  • Apply your sound knowledge of the regulatory landscape to ensure standard compliant SaMD implementation, working to Quality Management Systems such as ISO 13485, 21CFR820, risk management to ISO14971, ISO 62304
  • Demonstrable knowledge and track record in SaMD development and / or bringing SaMD’s to market, including translation of user needs into specifications, specification of intended uses, design verification / validation and regulatory submissions
  • Experience in medical device software development for Class II and above medical devices
  • Excellent quality mindset, attention to detail and documentation practice in regulated environment as design controls
  • Substantial experience with the fast lifecycle of mobile applications development and / or deployment in the pharmaceutical environment
  • Sound knowledge of legislation, regulation, industry standards and guidance within the area of medical devices incl. specifically SaMD
  • Strong interpersonal skills combined with a customer service orientation and strong sense of urgency as well as the flexibility and the ability to balance multiple tasks and timelines simultaneously are necessary for this exciting position
  • Effective communication skills with internal and external customers at all levels
  • Fluent in English and preferably also in German
  • Bewerben
    Zu Favoriten hinzufügen
    Aus Favoriten entfernen
    Bewerben
    Meine Email
    Wenn Sie auf "Fortfahren" klicken, stimmen Sie zu, dass neuvoo Ihre persönliche Daten, die Sie in diesem Formular angegeben haben, sammelt und verarbeitet, um ein Neuvoo-Konto zu erstellen und Sie gemäß unserer Datenschutzerklärung per Email zu benachrichtigen. Sie können Ihre Zustimmung jederzeit widerrufen, indem Sie diesen Schritten folgen.
    Fortfahren
    Bewerbungsbogen