Senior Danger Administration Specialist

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The Senior Danger Administration Specialist can be answerable for growing, sustaining, and supporting the corporate’s risk management file. You may be a part of the event crew of our imaging system, to search out the absolute best options to deal with challenges and implement a risk-based strategy to medical machine growth. Key obligations for this function embrace Apply technical excellence and management for advanced methods to attain 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, challenge crew, and cross-functional stakeholders. Develop and replace Design Historical past File information to help 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 so on.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and so on.); Danger Administration Report; Danger Controls; Danger Coverage; Harms Record. What you provide Demonstrable understanding and utility of Design Controls per 21 CFR 820.30 and Danger 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. Palms-on mindset with problem-solving abilities and nice consideration to element additionally whereas multitasking. Means to work in cross-functional groups that span world operations Technical understanding of advanced 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 attain product growth objectives. Sturdy 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, methods or software program engineering, publish graduate is a plus. What we provide Working in a start-up growing innovative imaging methods enhancing healthcare. Changing into a part of a dynamic, multi-national crew of extremely expert people with a really sturdy concentrate on crew tradition and particular person growth. A everlasting contract in an award-winning start-up. Versatile working surroundings and a world tradition in addition to places of work in Germany and Eire.
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