Roche is committed to being a leader in the field of digital health and is focused on creating solutions that improve the lives of our patients. In a global, cross-functional environment the Device Development Department within Pharma Technical Development is contributing the overall technical success and strategic management of connected drug delivery devices and software as a medical device products.
As a member of Device Development at Roche, the Senior Software as Medical Device (SaMD) Engineer will support the development of SaMD’s by providing smart hardware, software, design control expertise and documentation support to a cross-functional team including QA, Regulatory Affairs, Clinical, Commercial and IT functions.
The specific responsibilities and key activities of this position include:
- 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
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 within our Device Development programs. Together with a university level education (engineering degree or related discipline) you bring a minimum 5 year proven track record in software development projects classified as SaMD preferable in the Pharmaceutical industry.
You will also have the following skills and experiences:
- 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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Roche is an equal opportunity employer.Technical Development, Technical Development > Medical Device Technology Development