Lead Software Engineer (m/f/d)

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

General Tasks

• Close collaboration within the development department and across the company to align medical-device software development activities and AI-supported engineering practices
• Contributing to company standards and ensuring their practical application in both regulated software development and AI-supported software development workflows
• Initiating and actively participating in measures related to process improvement, standardization, waste elimination, and the effective use of AI-supported development methods
• Active participation in the innovation process, with special attention to AI-supported software engineering and its responsible use in medical-device development
• Strict compliance with quality, occupational safety, and environmental regulations and implementation of the instructions of quality/environmental management representatives and the occupational safety specialist

• 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 (*) Common European Framework of Reference for Languages (CEFR)