Senior R&D / NPI Project Engineer – Wound Care
Farnborough | Full-time | On-site
We are supporting a leading wound care medical device manufacturer in the search for a Senior R&D / NPI Project Engineer to lead complex new product introduction and design transfer activities within a regulated environment.
This is a senior, hands-on role sitting within R&D, reporting directly into the CTO, with real ownership of projects from concept through design transfer and early production.
The Role
As Senior R&D / NPI Project Engineer, you will provide technical leadership across cross-functional teams to deliver innovative wound care products into manufacturing. You’ll own design outputs, risk management, validation strategy, and ensure products are transferred into production efficiently, compliantly, and on time.
You’ll act as the senior engineering interface internally and externally, making independent, risk-based engineering decisions and mentoring junior engineers along the way.
Key Responsibilities
* Lead NPI and design transfer projects from concept through to manufacturing and early production
* Act as technical lead for assigned projects, interfacing with customers and senior stakeholders
* Own design control documentation, including drawings, BOMs, specifications, DMRs, inspection and manufacturing procedures
* Lead and own risk management activities in line with ISO 14971 (plans, reports, reviews)
* Work closely with Quality & Regulatory to ensure ISO 13485 compliance and successful design transfer
* Support and lead process validation activities (IQ/OQ/PQ)
* Drive DFM/DFA considerations throughout development
* Support supplier selection, component specification reviews, and technical assessments
* Lead or support engineering change activity across the product lifecycle
* Act as technical authority during scale-up, validation, and early production
* Mentor and technically develop junior engineers
* Drive continuous improvement based on manufacturing data, field feedback, and post-market surveillance
* Contribute to new and novel IP
What We’re Looking For
* Degree-qualified in Engineering (or HNC/HND with strong experience)
* Typically 5–8+ years’ experience in regulated product development and design transfer
* Experience within medical devices preferred (wound care highly desirable)
* Strong knowledge of ISO 13485, design controls, and regulated NPI environments
* Proven experience with design verification, validation, and transfer to manufacturing
* Confident leading technical discussions and influencing without authority
* Strong experience with risk management, FMEA, and process validation
* Comfortable making independent engineering decisions in regulated settings
* Proficient with SolidWorks or equivalent CAD
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