Job Description:

• 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.

Requirements/Qualifications:

• 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