NPI Engineer

Euro Projects Recruitment; Shippon; On-site; GBP 40,000 - 45,000; Full time

Benefits offered by this job

Career development

Exposure to regulated manufacturing

Job summary

Euro Projects Recruitment is seeking an experienced NPI Engineer to lead industrialisation and technology transfer of medical device products into controlled manufacturing. You will collaborate with Engineering, Quality, Production, Supply Chain and Validation to ensure products, processes and documentation are prepared for manufacture.

You will own NPI plans, validate processes, maintain documentation, and lead cross-functional teams to translate requirements into repeatable manufacturing.

Qualifications

• Engineering degree or equivalent
• Experience within medical devices or another highly regulated industry.
• Working knowledge of ISO 13485.
• Previous experience in NPI, manufacturing engineering, process development, industrialisation or technology transfer.
• Experience creating controlled manufacturing documentation.
• Ability to interpret engineering drawings, specifications and technical data.
• Experience leading cross-functional technical projects and coordinating SMEs.
• Strong problem-solving and analytical skills.
• Excellent communication skills and the ability to influence technical decisions across functions.

Responsibilities

• Own NPI and technology-transfer plans, including deliverables, schedules, readiness criteria, actions and decisions.
• Ensure manufacturing processes are robust, controlled and validated.
• Ensure NPI and manufacturing activities meet quality and regulatory standards (ISO 13485).
• Lead cross-functional SME teams translating product and customer requirements into repeatable processes.
• Plan engineering trials, pilot builds, validation builds and initial production runs.
• Identify and resolve technical gaps before manufacturing release.
• Assess transferred processes for production volume, equipment, facilities, personnel and environment.
• Provide hands-on engineering support during initial production until processes are stable and transferred.

Skills

Engineering degree

ISO 13485

NPI / Technology transfer

Problem solving

Communication

Regulated manufacturing

Education

Engineering degree or equivalent

Job description

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 within 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 controlled manufacturing documentation.
• The ability to interpret engineering drawings, specifications and technical data.
• Experience leading cross-functional technical projects and coordinating subject matter experts.
• Strong problem-solving and analytical skills.
• Excellent communication skills and the ability to influence technical decisions across different functions.
• Experience within medical devices, precision engineering, pharmaceuticals, aerospace, automotive or another highly regulated manufacturing environment may be relevant, provided you have strong NPI and controlled manufacturing experience.

Why Apply?

This is an excellent opportunity for an experienced NPI Engineer or Manufacturing Engineer to take ownership of the transition of innovative medical device products from development into production. You will have genuine responsibility for NPI, industrialisation, technology transfer, manufacturing process development and validation, rather than simply supporting an established production process. The role offers exposure to the complete journey from engineering and product development through to manufacturing readiness, validation and initial production, making it particularly attractive to an engineer who enjoys solving technical problems and working across multiple disciplines. You will also have the opportunity to develop your experience within the highly regulated medical device industry, working to ISO 13485 and contributing to products where quality, reliability and patient outcomes are critical.

This NPI Engineer job is commutable from Oxford, Didcot, Abingdon, Wantage, Witney, Bicester, Aylesbury, Faringdon, Swindon and surrounding areas.

We are committed to finding the right person for the role and encourage all qualified individuals to apply.

This job is posted by Euro Projects Recruitment, a recruitment consultancy specialising in engineering and manufacturing appointments from tool room to boardroom. We combine over 100 years of technical knowledge and recruitment expertise to introduce the best candidates to the best companies. We are passionate about your future and persistent in our efforts to secure you the right job.