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
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