Senior Danger Administration Specialist

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The Senior Danger Administration Specialist shall be chargeable for creating, sustaining, and supporting the corporate’s risk management file. You may be a part of the event staff of our imaging system, to search out the absolute best options to handle challenges and implement a risk-based strategy to medical gadget improvement. Key tasks for this function embrace Apply technical excellence and management for complicated methods to realize secure and efficient designs for brand spanking new and present 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 staff, and cross-functional stakeholders. Develop and replace Design Historical past File data to help each High quality and Regulatory documentation. Observe design management processes whereas producing and reviewing risk management deliverables, together with: Danger Administration Plan; Recognized and foreseeable hazards; Danger Evaluation ({hardware}, software program, cybersecurity, usability, interoperability, and so on.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and so on.); Danger Administration Report; Danger Controls; Danger Coverage; Harms Checklist. What you supply 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. Palms-on mindset with problem-solving expertise and nice consideration to element additionally whereas multitasking. Capacity 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 gadget design and improvement is a plus. Demonstrated expertise in main inside and exterior improvement assets to realize 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 enhancing healthcare. Changing into a part of a dynamic, multi-national staff of extremely expert people with a really sturdy deal with staff tradition and particular person improvement. 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.
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