Our client a high potential start-up company are currently seeking a Senior R&D Engineer to join their team. The Senior R&D Engineer will be responsible for the design, development and testing of medical devices. The role will involve working with Engineering, Quality and Regulatory teams to ensure devices meet user need requirements, regulatory requirements and that activities are completed in compliance to ISO 13485 and 21 CFR 820 requirements. The candidate will report to the Chief Technical Officer (CTO) and work across all stages of device development, from prototyping, final manufacture, clinical investigation and commercialisation. A hands-on approach to projects with a good attitude and work ethic is essential, with an ability to work in a cross functional, flexible and small entrepreneurial environment.Role/Responsibilities:Work closely with clinicians, quality, regulatory and clinical to develop innovative medical devicesSupport the CTO in current product development and pipeline products, through all aspects of the product development processEnsure all work is carried out in compliance with Quality, Regulatory and company policies and systems.Assess new product concepts through technical analyses of competitor products, literature reviews, IP landscape and working with regulatory to establish route to marketParticipate in the creation and maintenance of product Risk Management Files.Select materials, components and equipment based on analysis of specifications, reliability and regulatory requirements.Participate in the control of manufacture of components and the assembly of devices for the purposes of design verification testing and clinical evaluation.Conduct engineering bench testing, CAD, prototyping, write technical aspects of patents, Finite element analysis.Compile documentation to support product development in accordance with the Medical Device Directive (MDD) andProVerum’s ISO 13485 Quality Management System - complete tasks including document control and writing protocols and test reports.He / She will be required to meet with European and U.S. contractors / suppliers on an as needs basis.Our client a high potential start-up company are currently seeking a Senior R&D Engineer to join their team. The Senior R&D Engineer will be responsible for the design, development and testing of medical devices. The role will involve working with Engineering, Quality and Regulatory teams to ensure devices meet user need requirements, regulatory requirements and that activities are completed in compliance to ISO 13485 and 21 CFR 820 requirements. The candidate will report to the Chief Technical Officer (CTO) and work across all stages of device development, from prototyping, final manufacture, clinical investigation and commercialisation. A hands-on approach to projects with a good attitude and work ethic is essential, with an ability to work in a cross functional, flexible and small entrepreneurial environment.Role/Responsibilities:Work closely with clinicians, quality, regulatory and clinical to develop innovative medical devicesSupport the CTO in current product development and pipeline products, through all aspects of the product development processEnsure all work is carried out in compliance with Quality, Regulatory and company policies and systems.Assess new product concepts through technical analyses of competitor products, literature reviews, IP landscape and working with regulatory to establish route to marketParticipate in the creation and maintenance of product Risk Management Files.Select materials, components and equipment based on analysis of specifications, reliability and regulatory requirements.Participate in the control of manufacture of components and the assembly of devices for the purposes of design verification testing and clinical evaluation.Conduct engineering bench testing, CAD, prototyping, write technical aspects of patents, Finite element analysis.Compile documentation to support product development in accordance with the Medical Device Directive (MDD) andProVerum’s ISO 13485 Quality Management System - complete tasks including document control and writing protocols and test reports.He / She will be required to meet with European and U.S. contractors / suppliers on an as needs basis.Skills/Experience:The successful candidate should be degree qualified in a relevant Engineering or Science discipline and have the following skills and experience.3-5 years’ experience in medical device industry or 1-2 year’s experience in combination with a postgraduate qualification (masters or PhD)Project planning skillsExcellent communication and writing skillsGood mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.Good working knowledge of Solidworks or other CAD packageKnowledge of FEA an advantageKnowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820) would be a distinct advantage
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