About this role
Job title: Technical Project Manager / System Architect (m/w/d)
About the Role Within Getinge's Maquet Cardiopulmonary GmbH in Rastatt, we seek a Technical Project Manager / System Architect to technically lead the development of electromechanical medical devices in ECMO, gas monitoring and gas mixing. The role requires close alignment with risk management, medical affairs, and software/hardware teams to ensure compliant, cross-functional system design.
What You'll Do
- Lead technical development of electromechanical medical devices in ECMO, gas monitoring and gas mixing
- Clarify technical project requirements considering the overall requirements management
- Create specifications for external development partners and evaluate technical concepts
- Ensure complete and efficient implementation across system boundaries with respect to standards, technology, and regulatory requirements
- Drive decisions and escalate critical issues
- Contribute to the creation of processes and continuous improvements
- Collaborate with risk management and medical affairs to align requirements
- Coordinate with software, hardware, mechanics, and disposable product teams regarding system design and safety concepts
What We're Looking For
- Successfully completed studies in Medical Technology, Mechatronics, Electrical Engineering or a comparable technical/scientific field with professional experience or equivalent qualification
- Several years of experience in the development of electromechanical systems/system architectures in the medical technology industry
- Knowledge of Systems Engineering
- Polarion and Jira; tool experience desirable
- Good product knowledge in ECMO applications (including disposables and sensors) desirable
- Very good knowledge of medical device standards (hardware and single-use products)
- Knowledge of development processes/methods (e.g., V-model) and relevant standards (ISO 13485, ISO 14971, etc.)
- Knowledge of functional safety IEC 61508, FMEA IEC 60812, FTA IEC 61025 and Reliability
- Knowledge of CE/FDA regulatory requirements is advantageous
- Very strong analytical skills with a highly structured and process-oriented approach
- Communication skills with a high level of motivation, independence and persuasiveness to implement new solutions
- Very good German and English language skills (spoken and written)
Compensation & Benefits
- High-quality products in a life-saving environment
- Remuneration according to metal tariff, 30 vacation days per year and other attractive terms
- Flexible, family-friendly working hours and mobile working
- JobRad and corporate benefits (employee discounts)
- Career opportunities in a renowned company
- Individual onboarding and training opportunities
- Modern workplace equipment