Bluebolt Recruitment

Medical Device R&D Manager (BB-A8716)

Found in: Neuvoo IE

We are seeking a Medical Device R&D Manager to work for a medical device manufacturer in Ireland developing state of the art orthopaedic devices.You should be a high calibre, senior level R&D engineer/executive that has successfully managed a team, design process and NPD project to develop a medical device product under the ISO13485 standard, from concept stage right through to product launch and post market follow up. In addition to being creative, resourceful and an Innovator, the successful candidate will have strong leadership capabilities; be a self-starter with a proven project management track record. The successful candidate will be highly self-motivated, a decision maker, entrepreneurial in spirit, and performance driven. Ideally the candidate will have experience of supervising small teams and therefore be an excellent communicator, influencer and motivator with a proven ability to build, manage and maintain relationships at all levels.This is a hands on role to manage and coordinate all activities relating to the NPD Programme. The manager will lead, support and work with the team to develop orthopaedic devices and technology, that will deliver clear clinical, functional and economic benefits to patients, practitioners and healthcare organisations worldwide. The manager will motivate and coordinate the development team to achieve their respective project objectives within specified time lines and:• Work closely with the R&D Director to implement the company’s strategy and achieve its business goals.• Ensure that technologies, products and devices are developed to comply with relevant regulatory standards and CE certification requirements.• Lead design reviews and V&V activities.• Coordinate transfer of R&D projects to pilot & series manufacturing and be familiar with all related quality and regulatory protocols necessary.• Support marketing to ensure timely product launches and manage the company’s training programme to train clinicians and customers on how to effectively use products so as to secure and accelerate product adoption in the market.• Support the Quality / regulatory function.• Contribute as required to the development of company strategy and future business plans.Qualifications Required:Min degree in any of the following disciplines: Mechanical or Polymer engineering, Industrial design, Quality, Chemistry, Biomechanics or Materials Science. Other relevant disciplines will be considered.Minimum experience and requirements:The candidate must have a minimum 3 years working in the medical device sector, have at least 2 years “Hands on” experience supervising a team in a R & D / product development environment, and have a proven programme/project management track record. Ideally, the candidate will have worked under an ISO or FDA regulatory system, have experience of product verification and validation procedures and techniques and is capable of managing NPD projects from conception to product commercialisation. Familiarity with design and development procedures and experience of building or contributing to a "design history file" during product development is a serious advantage.Experience of patents and IP, including preparation of patent specifications, is a distinct advantage, as is set-up and V&V experience of manufacturing systems and the preparation of technical agreements and protocols.Experience of tool design and injection moulding is an advantage as is experience with CAD drawing packages.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 development manager design manager R&D manager research manager medical device manager medical device leader

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location_onWaterford, Ireland

work Bluebolt Recruitment

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