Lead Software Engineer (mfd)

This position is part of Novantas Advanced Surgery business unit. Specialized in the field of Minimally Invasive Medicine Novanta Medical develops devices and accessories so that doctors can operate with small cuts. We produce Cameras Insufflators Medical Pumps and tubing that makes diagnosis and treatment easier for everyone. Our insufflators and pump systems dilate cavities in the body and turn previously complicated surgeries into minor procedures. Together with customers doctors and technical experts our teams continuously search for new ways to innovate.

Primary Responsibilities

• Leading software development for medical devices and guiding engineers in the implementation of software solutions
• Leading the transformation from classical software development to AI-supported software development within the team
• Requirements analysis based on the functional specification or other requirements
• Creating and reviewing software requirements and maintaining the required software and device documentation for medical-device development including documentation needed for compliance traceability and product lifecycle support
• Conducting design and code reviews
• Independent planning of tasks for oneself and the team
• Creation and execution of software tests
• Analysis and correction of software modules in highly complex error cases
• Applying software standards and ensuring standards within the team
• Creating and maintaining comprehensive technical and regulatory documentation to ensure compliance with FDA and ISO 13485/IEC 62304 standards
• Further development of internal software standards
• Assumption of advanced technical or organizational roles within the organization (e.g. Product Owner)
• Leading and organizing training sessions on software development practice tools and standards
• Support for strategic decisions in the specialist area through preparation evaluation recommendation and advice

Additional Responsibilities

• Leading software development for regulated medical devices and supporting engineers in complex implementation decisions
• Identifying evaluating and introducing AI-supported software development practices tools and workflows in the specialist area
• Supervision of students and external development service providers with focus on technical quality regulatory expectations and team learning
• Assessment of the impact of changes to standards technologies and AI-supported development methods on the specialist area
• Independent mentoring of new employees and engineers in software development practices
• Participation in the hiring process for new employees with focus on technical leadership capability and readiness for AI-supported software development
• Support in the performance evaluation of employees by providing technical input on software engineering skills collaboration and development practices
• Participation where appropriate in specialist conferences and external committees to monitor trends in medical-device software development and AI-supported engineering
• Advising management on business and technology decisions related to software development leadership and AI-supported software engineering

Required Experience Education Skills Training and Competencies

• Degree in computer science electrical engineering mechatronics systems engineering automation engineering or equivalent
• Approximately 2 years experience in leading software development for regulated medical devices and guiding engineers in the implementation of software solutions
• Strong understanding of AI-supported software development approaches and practices with the ability to lead their adoption within a development team
• Very good knowledge of system development software architecture and software design
• Extensive knowledge of embedded software development in C/C sufficient to provide technical direction review solutions and guide implementation decisions
• Experience providing technical guidance mentoring engineers and ensuring high-quality implementation in software projects
• Confident use of software development tools AI-supported engineering approaches and Microsoft Office
• Good verbal and written English skills (CEFR B2)*
• Desirable: knowledge in the areas of electrical engineering and transmission protocols
• Strong leadership mindset with the ability to guide engineers set technical direction and create alignment in software development activities
• High willingness and capability to drive change especially the transformation from classical software development to AI-supported software development
• Quality-conscious trustworthy and reliable
• Team-oriented communicative and able to influence without relying on direct disciplinary authority
• Structured and systematic working style with the ability to translate strategic goals into practical team practices

Travel Requirements

• Willingness to travel to all sites and business contacts up to a maximum of 10% travel