R&D Senior NPI Project Engineer

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.