Bluebolt Recruitment

Senior Medical Device Product Development Engineer (BB-3CD02)

Found in: Neuvoo IE

We are seeking a Senior R&D Product Development Engineer to work for a medical device manufacturer in Ireland developing state of the art orthopaedic devices.General Duties & Responsibilities * Reporting to the R&D Manager * Product/device development at all phases (idea generation through to commercialisation) * Generation and testing of prototypes and sample products * Material development * Manufacturing and process development * Carry out Design & Development procedures, FMEcA, Risk analysis etc. * Follow project plans in line with company objectives. * Liaison with Universities, Institutes, suppliers and commercial organisations when required. * Work to achieve goals and objectives as defined in R&D project plans * Support operations to source and validate suppliers and ensure necessary materials are available when required for the R&D programme and manufacturing. * Liaise with appointed Quality and regulatory affairs coordinator. * Monitor regulatory issues relating to medical devices under development. * Patents: searching and preparation of patent drafts with validated information and specifications * Ensure that product development is compliant with the company’s regulatory and quality systems, procedures, documentation, audits, and compliance for CE marking etc. * Generation and control of documentation for design history and technical files etc.Qualifications:Min 2.1 Degree in any of the following disciplines: Mechanical, Industrial design, manufacturing, Polymer engineering, Chemistry, Biomedical or Materials Science.Minimum experience and requirements:The candidate must have a minimum of 4 years “Hands on” product development experience, ideally in medical devices, with exposure to product verification and validation procedures and techniques. The candidate will have worked under an ISO 13485 or a related quality / regulatory system and is capable of delivering and maintaining momentum to achieve project milestones. Familiarity with design and development procedures and experience of building or contributing to a “design history file” during product development is a distinct advantage. Experience in any of the following areas will be considered favourably: textiles, polymers, materials, orthopaedics, drafting, 3D Cad packages, prototyping, biomechanics (gait and plantar foot pressure mapping) etc. Familiarity with industrial robots and programming is beneficial.Key words: medical device engineer medical device design engineer medical engineer biomedical engineer medical design engineer biomedical design engineer biomedical engineering medical engineering mechanical engineer polymer engineer industrial design engineer product design engineer

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info Permanent

location_onWaterford, Ireland

work Bluebolt Recruitment

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