Senior Danger Administration Specialist

Newest Jobs from Germany Reed At the moment.

The Senior Danger Administration Specialist will probably be chargeable for growing, sustaining, and supporting the corporate’s risk management file. You’ll be a part of the event workforce of our imaging system, to search out the very best options to handle challenges and implement a risk-based method to medical machine growth. Key obligations for this function embody Apply technical excellence and management for advanced techniques to realize secure and efficient designs for brand spanking new and current product platforms. Drive risk management actions, together with the incorporation of relevant medical requirements. Put together, current, and lead formal/casual evaluations of outcomes, deigns, and analyses, and drive alignment with friends, mission workforce, and cross-functional stakeholders. Develop and replace Design Historical past File data to assist each High quality and Regulatory documentation. Observe design management processes whereas producing and reviewing risk management deliverables, together with: Danger Administration Plan; Identified and foreseeable hazards; Danger Evaluation ({hardware}, software program, cybersecurity, usability, interoperability, and many others.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and many others.); Danger Administration Report; Danger Controls; Danger Coverage; Harms Checklist. What you provide Demonstrable understanding and software of Design Controls per 21 CFR 820.30 and Danger Administration per ISO 14971:2019. Demonstrable understanding and software of Design, Use and Manufacture risk-related evaluation methodologies, together with however not restricted to FMEAs, FTAs and Medical Hazard Evaluation. Fingers-on mindset with problem-solving abilities and nice consideration to element additionally whereas multitasking. Potential to work in cross-functional groups that span world operations Technical understanding of advanced technical techniques involving mechanical and mechatronic techniques, electronics, acoustics, software program, and sign processing. Expertise with intravascular catheter or minimally invasive machine design and growth is a plus. Demonstrated expertise in main inside and exterior growth sources to realize product growth objectives. Robust work ethic with a team-oriented mindset. Earlier Startup expertise is a plus. Glorious communication skills in English BE/BEng diploma in biomedical, mechanical, electrical, techniques or software program engineering, put up graduate is a plus. What we provide Working in a start-up growing innovative imaging techniques bettering healthcare. Turning into a part of a dynamic, multi-national workforce of extremely expert people with a really sturdy concentrate on workforce tradition and particular person growth. A everlasting contract in an award-winning start-up. Versatile working surroundings and a global tradition in addition to places of work in Germany and Eire.
source
Newest job vacancies on our jobs recruitment portal.