New Product Introduction Project Manager

Senior R&D NPI Project Engineer

Farnborough | Full Time

Apply below after reading through all the details and supporting information regarding this job opportunity.

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 xwzovoh 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.