At a Glance
- Tasks: Lead innovative projects in medical device development from concept to launch.
- Company: Join a rapidly growing company focused on advanced wound care solutions.
- Benefits: Enjoy flexible hours, competitive salary, and strong career progression.
- Other info: Collaborative environment with opportunities for technical leadership and mentoring.
- Why this job: Make a real impact in healthcare with cutting-edge technologies.
- Qualifications: 5+ years in regulated product development and strong NPI experience required.
The predicted salary is between 50000 - 65000 £ per year.
Our client is an innovative and rapidly growing medical device company specialising in advanced wound care solutions. With a strong focus on product innovation, quality, and continuous improvement, they are looking to expand their R&D function with the addition of an experienced Senior R&D NPI Project Engineer.
This is an excellent opportunity to join a collaborative and forward-thinking business where you will play a key role in bringing new medical device products from concept through to manufacture and commercial launch.
As Senior R&D NPI Project Engineer, you will lead complex New Product Introduction (NPI), design transfer, and product development projects within a regulated medical device environment. Acting as a technical lead across cross-functional teams, you will be responsible for driving innovation, ensuring compliance with quality and regulatory standards, and delivering robust manufacturing-ready solutions.
You will work closely with R&D, Quality, Regulatory, Manufacturing, and external customers/suppliers to ensure successful product development and transfer into production.
Key Responsibilities- Lead and manage NPI and design transfer projects from concept through to manufacturing release
- Act as the primary technical contact for customers during development activities
- Drive technical innovation and problem-solving across product and process challenges
- Produce and maintain design control documentation including:
- Drawings
- BOMs
- Material specifications
- DMR documentation
- Manufacturing and inspection procedures
- Support risk management activities in line with ISO 14971
- Lead FMEA activities and support validation activities including IQ/OQ/PQ
- Work closely with Quality and Regulatory teams to ensure compliance with ISO 13485 and medical device standards
- Support supplier selection, technical reviews, and component approvals
- Lead engineering changes and lifecycle management activities for existing products
- Provide technical leadership and mentoring to junior engineers
- Drive Design for Manufacture (DFM) and Design for Assembly (DFA) principles throughout development
- Support scale-up, validation, and early production phases
- Contribute towards continuous improvement and new intellectual property development
- Essential
- Degree, HNC, or HND in Engineering or a related discipline
- 5+ years' experience within regulated product development environments
- Strong experience in NPI, design transfer, and product development
- Experience working within medical devices or highly regulated industries such as aerospace or automotive
- Knowledge of ISO 13485 and design control requirements
- Experience with risk management, FMEA, and validation activities (IQ/OQ/PQ)
- Ability to create technical documentation and validation reports
- Strong communication and stakeholder management skills
- Experience working cross-functionally within engineering and manufacturing teams
- Ability to work independently and lead technical decision-making
- Desirable
- Experience supporting FDA or CE submissions
- Experience acting as technical lead on regulated projects
- Supplier audit or qualification experience
- CAD experience, ideally SolidWorks or equivalent
- Strong understanding of cGMP/FDA standards
- Opportunity to join a growing and innovative medical device business
- Involvement in cutting-edge wound care technologies
- Strong career progression opportunities
- Collaborative and technically driven environment
- Flexible working hours
- Competitive salary and benefits package
If you are an experienced NPI or R&D Engineer looking for a technically challenging position with genuine growth opportunities, we would love to hear from you.
New Product Introduction Project Manager in Farnborough employer: Maclivaro Limited
Join a pioneering medical device company in Farnborough, where innovation meets collaboration. As a Senior R&D NPI Project Engineer, you will thrive in a supportive environment that prioritises employee growth and offers flexible working hours, competitive salaries, and the chance to work on cutting-edge wound care technologies. This is an exceptional opportunity to make a meaningful impact while advancing your career in a forward-thinking organisation.
StudySmarter Expert Advice🤫
We think this is how you could land New Product Introduction Project Manager in Farnborough
✨Network Like a Pro
Get out there and connect with people in the industry! Attend events, join online forums, or even reach out to folks on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Show Off Your Skills
When you get the chance to chat with potential employers, make sure to highlight your experience with NPI and design transfer projects. Share specific examples of how you've driven innovation and tackled challenges in regulated environments. This will help you stand out!
✨Prepare for Interviews
Do your homework before interviews! Research the company and their products, and be ready to discuss how your background aligns with their needs. Practise common interview questions, especially those related to compliance and quality standards in medical devices.
✨Apply Through Our Website
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search. So, go ahead and submit your application today!
We think you need these skills to ace New Product Introduction Project Manager 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 showcase your skills in NPI and design transfer.
Craft a Compelling Cover Letter:Your cover letter should tell us why you're the perfect fit for this role. Share your passion for medical devices and innovation, and don’t forget to mention how your background aligns with our focus on quality and continuous improvement.
Showcase Your Technical Skills:In your application, be sure to highlight your technical expertise, especially in areas like risk management, FMEA, and validation activities. We want to see how you can drive innovation and problem-solving in our projects.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity in our collaborative team.
How to prepare for a job interview at Maclivaro Limited
✨Know Your NPI Inside Out
Make sure you brush up on your knowledge of New Product Introduction processes. Be ready to discuss specific projects you've led, the challenges you faced, and how you overcame them. This will show your potential employer that you have the hands-on experience they’re looking for.
✨Familiarise Yourself with Regulations
Since this role is in a regulated environment, it’s crucial to understand ISO 13485 and other relevant standards. Prepare examples of how you've ensured compliance in past projects, as this will demonstrate your ability to navigate the complexities of medical device development.
✨Showcase Your Technical Leadership
Be prepared to talk about your experience leading cross-functional teams. Highlight instances where you acted as a technical lead, mentored junior engineers, or drove innovation. This will illustrate your capability to manage diverse teams and foster collaboration.
✨Prepare for Problem-Solving Questions
Expect questions that assess your problem-solving skills, especially related to design transfer and risk management. Think of specific examples where you identified a problem, implemented a solution, and the impact it had on the project. This will showcase your analytical thinking and proactive approach.
