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Senior R&D NPI Project Engineer Farnborough | Full Time The Company Our client is an innovative and rapidly growing medical device company specialising in advanced wound care solutions. With a strong focus on product innovation, quality, and continuous improvement, they are looking to expand their R&D function with the addition of an experienced Senior R&D NPI Project Engineer. This is an excellent opportunity to join a collaborative and forward-thinking business where you will play a key role in bringing new medical device products from concept through to manufacture and commercial launch. The Role As Senior R&D NPI Project Engineer, you will lead complex New Product Introduction (NPI), design transfer, and product development projects within a regulated medical device environment. Acting as a technical lead across cross-functional teams, you will be responsible for driving innovation, ensuring compliance with quality and regulatory standards, and delivering robust manufacturing-ready solutions. You will work closely with R&D, Quality, Regulatory, Manufacturing, and external customers/suppliers to ensure successful product development and transfer into production. Key Responsibilities • Lead and manage NPI and design transfer projects from concept through to manufacturing release, • Act as the primary technical contact for customers during development activities, • Drive technical innovation and problem-solving across product and process challenges, • Produce and maintain design control documentation including:, • Drawings, • BOMs, • Material specifications, • DMR documentation, • Manufacturing and inspection procedures, • Support risk management activities in line with ISO 14971, • Lead FMEA activities and support validation activities including IQ/OQ/PQ, • Work closely with Quality and Regulatory teams to ensure compliance with ISO 13485 and medical device standards, • Support supplier selection, technical reviews, and component approvals, • Lead engineering changes and lifecycle management activities for existing products, • Provide technical leadership and mentoring to junior engineers, • Drive Design for Manufacture (DFM) and Design for Assembly (DFA) principles throughout development, • Support scale-up, validation, and early production phases, • Contribute towards continuous improvement and new intellectual property development Requirements Essential • Degree, HNC, or HND in Engineering or a related discipline, • 5+ years’ experience within regulated product development environments, • Strong experience in NPI, design transfer, and product development, • Experience working within medical devices or highly regulated industries such as aerospace or automotive, • Knowledge of ISO 13485 and design control requirements, • Experience with risk management, FMEA, and validation activities (IQ/OQ/PQ), • Ability to create technical documentation and validation reports, • Strong communication and stakeholder management skills, • Experience working cross-functionally within engineering and manufacturing teams, • Ability to work independently and lead technical decision-making Desirable • Experience supporting FDA or CE submissions, • Experience acting as technical lead on regulated projects, • Supplier audit or qualification experience, • CAD experience, ideally SolidWorks or equivalent, • Strong understanding of cGMP/FDA standards What’s on Offer • Opportunity to join a growing and innovative medical device business, • Involvement in cutting-edge wound care technologies, • Strong career progression opportunities, • Collaborative and technically driven environment, • Flexible working hours, • Competitive salary and benefits package If you are an experienced NPI or R&D Engineer looking for a technically challenging position with genuine growth opportunities, we would love to hear from you.

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Manufacturing Process Engineer (NPI Projects) -.

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