Medical Devices Project Engineer (Design, Sub-contract Manufacture)

SJB Technical Recruitment Ltd ,
Oxford, Oxfordshire
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Overview

Medical Devices Project Engineer ( Design, Sub-contract Manufacture, Quality) Oxford £Neg Our client is a successful Medical Devices company bringing an innovative family of products to market. The products are a complex and challenging instruments, combining electrical and electronic systems, power management, motor controls, sensors and communication systems. They are designed and manufactured by a combination of the in-house team and external consultants and sub-contract manufacturers. The Project Engineer will be responsible for managing these and other activities and this is a fantastic opportunity for a dynamic, organised graduate level engineer with at least one year of industrial experience of the medical devices industry Responsibilities · Supporting the CTO, Lead Software Engineer and Quality and Regulatory team in the development and validation of all technical design aspects. · Providing project support to the design consultants and sub-contract manufacturers of the device as required including occasional travel to Europe and N. America · Project manage the development of new and existing products through project gates and phase reviews · Ensuring that updates and changes to the electro-mechanical design and software of the device are fully incorporated into the product and accompanying technical design and control documentation. To assist the Engineering Manager and the Regulatory Affairs Manager in risk management as applicable to medical devices under ISO 14971:2007. Skills and Experience Understanding of the design, development, validation and manufacture of medical devices Familiarity with the regulatory requirements for medical devices for compliance quality standards, with working knowledge of ISO 14971, EN 60601 and ISO 13485 Ability to review and update Technical Reports to a high standard Able to demonstrate problem solving skills Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team Ability to work effectively with outside suppliers and manufacturers Ability to manage one or more multi-disciplined, multi-stakeholder projects Qualifications A first degree in electronic engineering, computer science or engineering systems or other relevant discipline 1 - 3 years’ experience working with medical devices in an industrial environment, this role could potentially suit a high calibre graduate with a year in industry. Full clean driving license and passport are required. This job was originally posted as www.totaljobs.com/job/89902258

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