University Bridge Fund



Senior Risk Management Specialist (m/f/d)



Munich, Germany
Posted on Friday, September 29, 2023
LUMA Vision GmbH Senior Risk Management Specialist (m/f/d)München AufgabeThe 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. QualifikationWe are looking for an experienced, enthusiastic, and multidisciplinary Senior Risk Management Specialist to join our highly skilled team. Demonstrable understanding and application of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019. Demonstrable understanding and application of Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis. Hands-on-mindset with problem-solving skills and great attention to detail also while multitasking. Ability to work in cross-functional teams that span global operations. Technical understanding of complex technical systems involving mechanical and mechatronic systems, electronics, acoustics, software and signal processing. Experience with intravascular catheter or minimally invasive device design and development is a plus. Demonstrated experience in leading internal and external development resources to achieve product development goals. Strong work ethic with a team-oriented mindset. Previous Startup experience is a plus. Excellent communication skills in English. BE/BEng degree in biomedical, mechanical, electrical, systems or software engineering, post graduate is a plus.Die vollständige Anzeige finden Sie beim Klick auf den Onlinebewerbungs-Button oder unter folgendem Link: