Senior Software as Medical Device (SaMD) Engineer 80-100% 80-100%
Inseriert am: 08.02.2019
We are looking from now on for a one-year contract (with option for prolongation), for our client F. Hoffmann-La Roche Ltd. in Basel, for a Senior Software as Medical Device (SaMD) Engineer 80-100%.
Your main duties:
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
Must-have requirements:
You bring significant expertise in smart devices, medical software, software validation, design controls, risk management, quality system documentation, and technical knowledge to support the SaMD activities
5-year proven track record in software development projects classified as SaMD preferable in the Pharmaceutical industry
University degree in engineering or related discipline
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
Are you interested? Eva Schwerzmann is looking forward to your complete application documents with photo.
