- Work closely with hardware and mechanical engineers to develop product software architecture and corresponding documentation
- Collaborate with stakeholders to develop software requirements specifications.
- Lead software risk management, software verification and validation activities.
- Work closely with firmware QA and testing teams either from Contract manufacturer or Software consultant.
- Work closely with design assurance, quality systems and regulatory teams to achieve company goals.
- 5+ years of embedded software development experience (preferably medical device software class B and C as per IEC62304 standard)
- Bachelor’s, master’s or PhD in electrical/electronic or computer science
- Demonstrated applied expertise in FDA requirements and medical device regulations including ISO 13485, ISO 14971, IEC 60601, IEC 62366, and IEC 62304.
- Experience working on connected medical devices (mobile and cloud supported devices).
- Solid experience in preparing technical files for supporting regulatory submissions (including CE mark, US FDA).
- Strong working knowledge of software development and configuration management tools (e.g., Jira, Git)
- Excellent written, oral communication and documentation skills