Medical Devices Engineering Manager (RF, Microwave, NPD, Project)

Medical Devices Engineering Manager (Electro mechanical, RF, Microwave, NPD, Project) Cardiff, Bristol To £70k plus benefits Our client is an innovative medical device company specialising in the design and development of cutting edge electro-mechanical medical devices and due to continued growth they now have an immediate requirement for a medical devices Engineering Manager leading the day to day development of new and existing devices. This spans all development stages from defining requirements, design, verification, documentation and handover to manufacturing. This role also takes the lead responsibility for ensuring that all technical regulatory submissions are compliant. Experience · Proven track record in leading medical device development projects and handover to manufacturing · Ability to lead projects to cost and time, spanning engineering, commercial, clinical and regulatory disciplines. · Excellent ability to communicate key issues and risks in a clear and timely manner and where necessary seek support to ensure the best possible project outcome. · Previous experience in gaining regulatory approval of active electronic and mechanical Medical Devices to achieve CE and FDA approval · A strong engineering background with substantial electronic and or mechanical design experience. · High power RF, microwave engineering, switch mode PSUs and analogue electronics is highly desirable · Achieving regulatory compliance to relevant standards overseeing design, development, verification and validation to BS EN 60601, ISO 14971, IEC 62366. · Good understanding of delivery of software projects and IEC62304 · Ability to manage external manufacturers, suppliers of components and sub-assemblies · Excellent verbal and written communication skills with strong sense of ownership · Ability to draft high quality technical documents to support regulatory submission · Excellent interpersonal skills and a proven ability to successfully lead and motivate a specialist development team · Degree qualified in a related engineering discipline preferred Additional Information: · Able to travel domestically and internationally as and when required. · Must have a current and valid UK / European driving licence. · Must have unrestricted right to work in the UK. · Needs to be flexible regarding all aspects of your job role and give your full support to all new systems / ideas that are implemented within the company. This job was originally posted as www.totaljobs.com/job/89929094