The public sector client is looking to recruit a Medical Product Development Engineer for a 6 month temporary contract, which is home-based. The successful candidate will have a valid DBS. Please Note: This assignment sits inside  of IR35.

Recruiting for a Product Development Engineer to join in the developing of IVD/Medical Device and single use disposable plastic kits. You will lead the development of kits working with a number of teams and very closely with Regulatory, Quality and Clinical. The position combines project management and hands-on activities, providing a unique variety to the role.

Key responsibilities and duties:
Manage development projects from requirements definition and concept development through to transfer to manufacture, using internal and external teams as required
Lead risk analysis discussions and preparation of the risk management file
Co-ordinate and input into the design of verification and validation testing
Prepare technical reports
Work with suppliers to obtain required technical documentation and certification
Work with regulatory to compile required technical file documentation
Work closely with use case teams
Ensure timely delivery of project milestones and provide suitable interpretation to directors, managers and staff within the organisation

• The successful applicant will have a relevant degree and sufficient experience and knowledge to undertake this work without significant management.
• Familiarity with mechanical design and materials science
• Experience in medical device product development
• Evidence of self strong project leadership in a multi-disciplinary commercial environment+ Evidence of experience in managing third parties to ensure quality and timely delivery of products

• Good IT skills (MS Office and Teams)
• Self-starter and quick learner
• Inquisitive and probing nature, with a keen interest in product design and development.
• Ability to assess new technical developments
• Good written and presentation skills,
• Flexibility and problem solver
• Evidence of effective communication, negotiation and inter-personal skills
• Evidence of ability to work with critical attention to detail and high levels of accuracy
• Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met

Projects must be documented to relevant medical device standards and must be conducted in accordance with ISO 13485 and to relevant standards such as IEC 62366, ISO 14971