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About the Role
Novanta Medical, part of Novanta’s Advanced Surgery business unit, specializes in Minimally Invasive Medicine. We develop devices and accessories such as Cameras, Insufflators, Medical Pumps, and tubing to aid doctors in performing surgeries with small incisions. Our insufflator and pump systems simplify complex surgeries by dilating body cavities, making diagnosis and treatment easier. We continuously innovate through collaboration with customers, doctors, and technical experts.
Responsibilities
- Lead software development for medical devices and guide engineers in implementing software solutions.
- Lead the transformation from classical software development to AI-supported software development within the team.
- Analyze requirements based on functional specifications.
- Create and review software requirements and maintain necessary documentation for medical-device development, including compliance, traceability, and product lifecycle support.
- Conduct design and code reviews.
- Independently plan tasks for self and the team.
- Create and execute software tests.
- Analyze and correct software modules in highly complex error cases.
- Apply and ensure software standards within the team.
- Create and maintain comprehensive technical and regulatory documentation to ensure compliance with FDA and ISO 13485/IEC 62304 standards.
- Further develop internal software standards.
- Assume advanced technical or organizational roles, such as Product Owner.
- Lead and organize training sessions on software development practices, tools, and standards.
- Support strategic decisions in the specialist area through preparation, evaluation, recommendation, and advice.
- Lead software development for regulated medical devices and support engineers in complex implementation decisions.
- Identify, evaluate, and introduce AI-supported software development practices, tools, and workflows.
- Supervise students and external development service providers, focusing on technical quality, regulatory expectations, and team learning.
- Assess the impact of changes to standards, technologies, and AI-supported development methods.
- Independently mentor new employees and engineers in software development practices.
- Participate in the hiring process for new employees, focusing on technical leadership capability and readiness for AI-supported software development.
- Support employee performance evaluations by providing technical input on software engineering skills, collaboration, and development practices.
- Participate in specialist conferences and external committees to monitor trends in medical-device software development and AI-supported engineering.
- Advise management on business and technology decisions related to software development leadership and AI-supported software engineering.
Requirements
- 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 implementation.
- Strong understanding of AI-supported software development approaches and practices, with the ability to lead their adoption.
- Very good knowledge of system development, software architecture, and software design.
- Extensive knowledge of embedded software development in C/C++ sufficient for technical direction, solution review, and implementation guidance.
- Experience providing technical guidance, mentoring engineers, and ensuring high-quality implementation.
- Confident use of software development tools, AI-supported engineering approaches, and Microsoft Office.
- Good verbal and written English skills (CEFR B2).
- Desirable: knowledge in electrical engineering and transmission protocols.
- Strong leadership mindset with the ability to guide engineers, set technical direction, and create alignment.
- High willingness and capability to drive change, especially the transformation to AI-supported software development.
- Quality-conscious, trustworthy, and reliable.
- Team-oriented, communicative, and able to influence without direct disciplinary authority.
- Structured and systematic working style with the ability to translate strategic goals into practical team practices.
- Willingness to travel up to 10%.
Skills
- Software development
- AI-supported software development
- Requirements analysis
- Software requirements
- Device documentation
- Design reviews
- Code reviews
- Task planning
- Software testing
- Software module analysis
- Software standards application
- Technical documentation
- Regulatory documentation
- FDA compliance
- ISO 13485 compliance
- IEC 62304 compliance
- Product lifecycle support
- System development
- Software architecture
- Software design
- Embedded software development in C/C++
- Technical guidance
- Mentoring engineers
- Software development tools
- AI-supported engineering approaches
- Microsoft Office
- Electrical engineering (desirable)
- Transmission protocols (desirable)
- Leadership
- Change management
- Teamwork
- Communication
- Influence
- Structured working style
- Systematic working style
Location
- All sites
Work Type
- Full-time
Experience Level
- Approximately 2 years' experience in leading software development for regulated medical devices
Education Level
- Degree in computer science, electrical engineering, mechatronics, systems engineering, automation engineering, or equivalent
About the Company
- Novanta Medical, part of Novanta’s Advanced Surgery business unit, specializes in Minimally Invasive Medicine.
- We develop devices and accessories such as Cameras, Insufflators, Medical Pumps, and tubing to aid doctors in performing surgeries with small incisions.
- Our insufflator and pump systems simplify complex surgeries by dilating body cavities, making diagnosis and treatment easier.
- We continuously innovate through collaboration with customers, doctors, and technical experts.