New Product Introduction Project Manager, Farnborough

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.