Jobs in Technik in München

The Senior Risk Management Specialist will be responsible for developing, maintaining and supporting the company's risk management file. You will be part of the development team of our imaging system, to find the best possible solutions to address challenges and implement a risk-based approach to medical device development. As part of your role you will oversee the risk management process of customized software and hardware and play a critical role in a startup environment with a dynamic group of innovators, shaping the future of imaging in healthcare. Apply technical excellence and leadership for complex systems to achieve safe and effective designs for new and existing product platforms. Drive risk management activities, including the incorporation of applicable medical standards. Prepare, present and lead formal/informal reviews of results, deigns and analyses and drive alignment with peers, project team and cross-functional stakeholders. Develop and update Design History File records to support both Quality and Regulatory documentation. Follow design control processes while generating and reviewing risk management deliverables, including: Risk Management Plan; Risk Analysis (hardware, software, cybersecurity, usability, interoperability, etc.); Traceability Report (hardware, software, cybersecurity, usability, interoperability, etc.); Risk Management Report; Support the planning and execution of verification and validation activities, with an emphasis on the demonstration of effectiveness of risk controls. Suggest, contribute and champion initiatives to improve the risk management activities and design control procedures. Familiarity with new product introduction/development (NPI)/ NPD). Understand the company's quality policy and quality system requirements applicable to tasks.