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.