Senior Threat Administration Specialist

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The Senior Threat Administration Specialist will likely be chargeable for creating, sustaining, and supporting the corporate’s risk management file. You can be a part of the event group of our imaging system, to search out the very best options to deal with challenges and implement a risk-based method to medical machine growth. Key duties for this position embrace Apply technical excellence and management for complicated methods to realize protected and efficient designs for brand new and current product platforms. Drive risk management actions, together with the incorporation of relevant medical requirements. Put together, current, and lead formal/casual opinions of outcomes, deigns, and analyses, and drive alignment with friends, venture group, and cross-functional stakeholders. Develop and replace Design Historical past File information to assist each High quality and Regulatory documentation. Comply with design management processes whereas producing and reviewing risk management deliverables, together with: Threat Administration Plan; Identified and foreseeable hazards; Threat Evaluation ({hardware}, software program, cybersecurity, usability, interoperability, and many others.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and many others.); Threat Administration Report; Threat Controls; Threat Coverage; Harms Record. What you provide Demonstrable understanding and utility of Design Controls per 21 CFR 820.30 and Threat Administration per ISO 14971:2019. Demonstrable understanding and utility of Design, Use and Manufacture risk-related evaluation methodologies, together with however not restricted to FMEAs, FTAs and Medical Hazard Evaluation. Arms-on mindset with problem-solving expertise and nice consideration to element additionally whereas multitasking. Means to work in cross-functional groups that span international operations Technical understanding of complicated technical methods involving mechanical and mechatronic methods, 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. Sturdy work ethic with a team-oriented mindset. Earlier Startup expertise is a plus. Wonderful communication skills in English BE/BEng diploma in biomedical, mechanical, electrical, methods or software program engineering, submit graduate is a plus. What we provide Working in a start-up creating innovative imaging methods enhancing healthcare. Turning into a part of a dynamic, multi-national group of extremely expert people with a really robust give attention to group tradition and particular person growth. A everlasting contract in an award-winning start-up. Versatile working atmosphere and a world tradition in addition to places of work in Germany and Eire.
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