Technical Reviewer - Active Medical Devices

About the position We exist to create positive change for people and the planet. Join us and make a difference too! BSI is seeking experienced R&D Engineers to join our Active Medical Devices team as a home-based Technical Specialist & Scheme Manager (Technical Reviewer). If you have hands on experience in the Research, Design or Manufacture of Active Medical Devices we'd love to hear from you. As a Technical Reviewer, you will work with medical device manufacturers throughout their certification life cycle to place active medical devices on the European market. This position applies a mix of engineering and design knowledge, newfound regulatory expertise, English writing skills, client and project management. You will assess cutting edge technology that will make a difference in patient health and safety and broaden your technical knowledge through ongoing training. Responsibilities • Review and evaluate medical device technical and clinical documentation in your areas of competence to assess compliance with MDD 93/42/EEC, MDR 2017/745 and UK MDR 2012 schemes. • Manage certification activities for a portfolio of medical device manufacturers, including determination of auditing requirements and making recommendations for the issue and maintenance of CE certifications. • Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes. • Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel. Requirements • A minimum of 5 years of design and development or research and development or testing experience with a variety of active medical devices. • Bachelor’s degree (or higher) in a discipline relevant to medical device manufacture and use. This may include electronic/electrical, electro-mechanical or biomedical engineering or medical physics. • Thorough knowledge of Medical Device regulation; at minimum an awareness of the requirements of IEC 60601 Third Edition and the risk management standard ISO 14971. • Understanding of the principles of design control and risk management. • Strong interpersonal communication skills. • Ability of prioritizing and executing individual workload. Benefits • BSI offers a competitive total reward package, an independent and varied job in an international environment, flexible working hours, ongoing training and development and a wide range of flexible benefits that you can tailor to suit your lifestyle.