Project Manager: Medical Device Software / SaMD (80 - 100%)
Role details
Job location
Tech stack
Job description
Join CISTEC as a Project Manager in Medical Software and shape healthcare.
Tasks
- Lead software development projects for SaMD and standalone software.
- Manage interdisciplinary teams and ensure project compliance.
- Support regulatory requirements and maintain technical documentation., Your tasks
- Responsibility for software development projects (Standalone Software / SaMD).
- Leading interdisciplinary project teams (development, product, UX, QM, RA).
- Planning, controlling, and monitoring time, costs, and scope.
- Ensuring project compliance according to our processes.
- Supporting the implementation of regulatory requirements according to MDR.
- Building and maintaining technical documentation.
- Risk management at project and product level.
- Reporting and analysis for program management / and management.
Requirements
- Experience in end-to-end software project management required.
- Proficiency in agile methodologies and software development processes.
- Strong communication and stakeholder management skills essential., * Experience in leading software projects end-to-end.
- Completed studies in computer science, medical technology, or a comparable field, ideally complemented by further training in project management.
- Proven success in market introduction and further development of products in regulated environments (medical devices, ideally SaMD).
- General knowledge of relevant standards (IEC 62304, ISO 14971, etc.).
- Experience with agile project management methods and modern software development processes.
- Strong communication and stakeholder management skills.
- Structured, independent, and proactive working style with a high implementation focus.
- Very good German skills in spoken and written form; English and French are an advantage.
Benefits & conditions
Meaningful work with impact: You work on exciting projects at the interface of AI and healthcare - in an interdisciplinary team that creates real added value.
Innovative environment: Together we develop pioneering solutions that sustainably improve clinical everyday life - with tangible impact for health professionals.
Flexible working: Part-time work, flexible working hours, and home office are a matter of course. After the probation period, you can work remotely up to four days a week.
Learning and innovation culture: We actively promote your further education and support you in attending specialist conferences and trade fairs. Flat hierarchies and an open, agile team environment create space for personal and professional development.
Attractive benefits: Enjoy 5 weeks of vacation per year. Unpaid leave is possible by arrangement.
Shared experiences: We celebrate successes together - at lunch barbecues, on snow days, or at our team and company events.