NPI Engineer

NPI Engineer, Medical Devices, £40,000 - £45,000, Oxfordshire Are you an NPI Engineer, Manufacturing Engineer, Process Engineer or Industrialisation Engineer with experience introducing new products and manufacturing processes within the medical device or another highly regulated industry? This is an excellent opportunity to join a growing and innovative medical device engineering company in Abingdon, Oxfordshire, where you will take a leading role in transferring new and modified products from development into controlled manufacture.

As NPI Engineer, you will bridge the gap between product development and production, converting engineering and design outputs into robust, repeatable and validated manufacturing processes. You will lead NPI and technology-transfer activities, coordinate cross-functional engineering teams and ensure products are ready for successful production in accordance with ISO 13485 and the company Quality Management System.

The Opportunity:

£40,000 - £45,000 salary guide  benefits. Join an innovative and growing medical device engineering business. Lead New Product Introduction (NPI) and technology transfer projects. Take products from development through to controlled manufacture. Work across manufacturing engineering, process development, validation and quality. Develop manufacturing processes, equipment, tooling and technical documentation Excellent opportunity for an experienced NPI Engineer, Manufacturing Engineer or Process Engineer

The Role NPI Engineer As an NPI Engineer, you will be responsible for leading the industrialisation and technology transfer of new and modified medical device products into controlled manufacturing. You will work closely with Engineering, Quality, Production, Supply Chain, Facilities, Validation, suppliers and customers to ensure that products, processes, equipment and documentation are fully prepared for manufacture. Your responsibilities will include:
Owning NPI and technology-transfer plans, including deliverables, schedules, readiness criteria, actions and technical decisions. Ensuring that manufacturing processes are robust, controlled and appropriately validated. Ensure that NPI and manufacturing activities meet the required quality and regulatory standards (ISO 13485). Leading cross-functional subject matter experts in translating product, design and customer requirements into repeatable manufacturing processes. Planning engineering trials, pilot builds, validation builds and initial production runs.

Identifying and resolving technical gaps before manufacturing release. Assessing whether transferred processes are suitable for the required production volume, equipment, facilities, personnel and environmental controls. Providing hands-on engineering support during initial production until processes are stable and formally transferred to Production. Developing and maintaining manufacturing documentation including process flows, Bills of Materials (BOMs), specifications, work instructions, travellers and inspection methods.

Defining manufacturing sequences, critical process parameters, operating limits, acceptance criteria and in-process controls. Specifying and introducing manufacturing equipment, tooling, jigs, fixtures, consumables and measurement equipment. Planning engineering trials, analysing process data and using the results to improve manufacturing processes. Maintaining traceability between product requirements, design outputs, manufacturing processes, risk controls, verification, validation and released documentation. Your Background NPI Engineer We are looking for an experienced NPI Engineer, Manufacturing Engineer, Process Engineer, Industrialisation Engineer or Technology Transfer Engineer with experience working in a controlled manufacturing environment.

You should have:
An Engineering degree or equivalent relevant practical engineering experience.

Experience with in medical devices or another highly regulated industry. Working knowledge of ISO 13485. Previous experience in NPI, New Product Introduction, manufacturing engineering, process development, industrialisation or technology transfer. Experience creating…