R&D Senior NPI Project Engineer

Overview An exciting opportunity for a Senior R&D Project Engineer to lead new product development and design transfer projects within a regulated environment. This role suits someone who enjoys technical ownership, cross-functional collaboration, and driving innovation from concept through to manufacturing.

Key Responsibilities Lead NPI and design transfer projects from concept to production. Act as the senior technical contact for customers, solving engineering challenges and ensuring successful delivery. Produce and manage design documentation (specifications, drawings, BOMs, DMRs, validation plans). Drive risk management activities in line with ISO 14971. Support process validation (IQ/OQ/PQ) and ensure smooth handover to manufacturing. Champion DFM/DFA and support supplier selection and component approval.

Mentor junior engineers and contribute to continuous improvement initiatives. Support product lifecycle activities, including changes and legacy product support. About You Essential:
Strong engineering background with experience in regulated product development (medical devices preferred). Solid understanding of design control, risk management, verification/validation, and quality systems (ISO 13485). Able to interpret technical drawings, write clear documentation, and make risk-based decisions. Confident communicator who can lead technical discussions and work independently. Experienced with validation tools (IQ/OQ/PQ), FMEA, and design transfer processes. Desirable:
Exposure to FDA/cGMP requirements. Experience supporting regulatory submissions (CE, FDA). Supplier qualification or technical audit experience. Ability to support or review design control files. Qualifications & Experience Engineering degree or equivalent (HNC/HND considered). Typically 58 years experience in R&D, NPI or design transfer within a regulated industry.