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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