Reporting to the CEO, the Director, R&D will proactively drive product development, engineering, clinical and regulatory efforts required to successfully submit a device for regulatory approval. Responsibilities include developing and managing of parallel projects schedules for internal and external engineering teams to meet project timelines and company’s objectives.
- Responsible for leading a medical device project through its entire lifecycle: specification and SOW development, creation of traceability matrix and risk management.
- Manage complex schedules that involve both internal and external engineering teams, while prioritizing activities for rapid execution of critical path work items.
- Manage the identification and development of mitigations for project risks.
- Lead team meetings, design/technical reviews, generate meeting minutes, task management and follow up action items to closure.
- Support the strategy of Regulatory and Clinical activities.
- Play key role in the development of the company’s QMS.
- Minimum 10 years of experience in management and development of FDA class II and EU Class I and II medical devices involving algorithms, software and electronics hardware.
- 10 years of hands-on experience in development of software products and systems.
- Solid understanding of design controls and risk management.
- Solid experience in supporting preparation of technical files for regulatory submissions (US FDA and CE). Strong program management experience working with R&D software engineering teams.
- Experience in C++ and Python.
- Experience in quasi real-time applications in Windows / Linux environment – an advantage.
- Proven experience in working with overseas partners / subcontractors.
- Understanding of all relevant standards to support medical device product development
- Familiar with ISO13485 Excellent written and verbal communication skills in the English language.
- This position requires occasional travel.
BS, MS in electrical engineering, computer science or biomedical engineering.