Head of Medical Device Software
Be responsible for complete software development life cycle including maintenance activities related to class IIb surgical robots and accessories – ranging from low-level firmware and applicative software up to data analytics in the cloud
Strategize and manage software development and verification teams (10 FTE) and resources, covering people development and capacity management.
Drive risk management activities (identification, assessment, prioritization, and risk control) for all software development and participate to overall project risk management activities with team.
Drive process and tools improvements supporting complete software development life cycle.
Account for delivering software product releases in a timely manner according to the Company’s product roadmap. Contribute to road-mapping activities and to project and product definitions.
Ensure compliance with relevant norms (e.g. ISO 13485, ISO 14971, IEC 62304, IEC 60601-1, IEC 80601-2-77) and regulations (e.g. MDD and MDR for Europe).
Establish and maintain appropriate documents and records in compliance with the Company’s QMS
At least 3 years in a leadership role in software development and V&V in medical device industry is mandatory.
Deep knowledge of software engineering, both process and tools (incl. continuous integration).
Experience performing software risk management for Class IIa (or higher) medical devices.
Solid understanding of structured product development (requirements-driven engineering, architecture modeling, detailed design, SW FMEA, formal verification, release processes, etc.).
Experience with development under medical device regulations (IEC 62304) and working within an ISO 13485 certified QMS.
Master degree or similar in a relevant discipline, such as Computer Science, Electronics and Electrical Engineering, Mechatronics (or similar).
Professional oral and written English. French a plus.