Description:
As Software Lead, you will take ownership of software development across the company's medical device platform. You will lead multidisciplinary software teams, drive technical strategy and remain hands-on in architecture, development and problem-solving.
This is a rare opportunity to play a leading role in bringing innovative wearable medical technology to market whilst helping establish the software foundations for future products and platform expansion.
Key Responsibilities
- Lead the software development of medical devices from early-stage development through to commercial release
- Ensure software development activities comply with IEC 62304 and support regulatory submissions, including FDA 510(k)
- Coordinate multidisciplinary software teams, including software engineers, algorithm developers, UI developers, SDK developers and external subcontractors
- Work closely with firmware, electronics and systems engineering teams to deliver integrated product solutions
- Remain actively involved in software architecture, technical decision-making, development and problem-solving
Experience & Skills Required
- Proven experience leading software development for regulated medical devices
- Strong understanding of IEC 62304 and the medical device software development lifecycle
- Experience supporting FDA 510(k) submissions and commercial product releases
- Previous experience leading multidisciplinary software teams and external development partners
- Strong systems-level understanding and experience working across software, firmware and hardware disciplines
- Hands-on technical background with the ability to contribute to architecture, development and troubleshooting activities