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The Senior Threat Administration Specialist will probably be accountable for creating, sustaining, and supporting the corporate’s risk management file. You can be a part of the event staff of our imaging system, to search out the absolute best options to deal with challenges and implement a risk-based strategy to medical system improvement. Key duties for this function embrace Apply technical excellence and management for complicated methods to attain secure and efficient designs for brand new and present product platforms. Drive risk management actions, together with the incorporation of relevant medical requirements. Put together, current, and lead formal/casual critiques of outcomes, deigns, and analyses, and drive alignment with friends, venture staff, and cross-functional stakeholders. Develop and replace Design Historical past File data 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; Recognized and foreseeable hazards; Threat Evaluation ({hardware}, software program, cybersecurity, usability, interoperability, and so forth.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and so forth.); Threat Administration Report; Threat Controls; Threat Coverage; Harms Record. What you provide Demonstrable understanding and software of Design Controls per 21 CFR 820.30 and Threat 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. Arms-on mindset with problem-solving abilities and nice consideration to element additionally whereas multitasking. Capability to work in cross-functional groups that span world 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 system design and improvement is a plus. Demonstrated expertise in main inside and exterior improvement sources to attain product improvement targets. Robust 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, publish graduate is a plus. What we provide Working in a start-up creating leading edge imaging methods bettering healthcare. Turning into a part of a dynamic, multi-national staff of extremely expert people with a really robust concentrate on staff tradition and particular person improvement. A everlasting contract in an award-winning start-up. Versatile working atmosphere and a world tradition in addition to workplaces in Germany and Eire.
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