At a Glance
- Tasks: Lead innovative projects in wound care from concept to production.
- Company: Leading medical device manufacturer with a focus on R&D.
- Benefits: Competitive salary, hands-on experience, and mentorship opportunities.
- Why this job: Make a real impact in healthcare by developing cutting-edge products.
- Qualifications: Degree in Engineering and 5-8 years in regulated product development.
- Other info: Dynamic role with opportunities for career growth and continuous improvement.
The predicted salary is between 48000 - 72000 £ per year.
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
New Product Introduction Engineer in Farnborough employer: Maclivaro Limited
Contact Detail:
Maclivaro Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land New Product Introduction Engineer in Farnborough
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry, especially those who have experience in wound care. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by diving deep into the company’s products and recent innovations. Show them you’re not just another candidate; you’re genuinely interested in their work and ready to contribute to their success.
✨Tip Number 3
Don’t underestimate the power of follow-ups! After an interview, drop a quick thank-you email to express your appreciation and reiterate your enthusiasm for the role. It keeps you fresh in their minds.
✨Tip Number 4
Apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you a leg up. Plus, it shows you’re keen on being part of our team!
We think you need these skills to ace New Product Introduction Engineer in Farnborough
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Senior R&D / NPI Project Engineer. Highlight your experience in regulated environments and any specific projects that relate to wound care or medical devices. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about this role and how your skills can contribute to our team. Be sure to mention your experience with ISO standards and risk management, as these are key for us.
Showcase Your Technical Skills: In your application, don’t forget to showcase your technical skills, especially with design control documentation and CAD software like SolidWorks. We’re keen to see how you’ve applied these skills in past roles, so give us some solid examples!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of applications and ensures you get all the updates directly from us. Plus, it shows you're keen on joining our team!
How to prepare for a job interview at Maclivaro Limited
✨Know Your Stuff
Make sure you brush up on your knowledge of ISO 13485 and design controls. Familiarise yourself with the specifics of wound care medical devices, as this will show your genuine interest and expertise in the field.
✨Showcase Your Leadership Skills
Prepare examples of how you've led NPI projects or mentored junior engineers in the past. Highlight your ability to interface with cross-functional teams and make independent, risk-based decisions.
✨Be Ready for Technical Questions
Expect questions about risk management, FMEA, and process validation. Think through scenarios where you've applied these concepts and be ready to discuss your approach and outcomes.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's current projects, challenges in the design transfer process, or their approach to continuous improvement. This shows your engagement and helps you assess if the role is a good fit for you.