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For Companies At a Glance
- Tasks: Lead innovative product development projects from concept to production in a regulated environment.
- Company: Join a forward-thinking company focused on medical device innovation.
- Benefits: Competitive salary, career growth, and opportunities for mentorship.
- Why this job: Make a real impact by driving innovation and solving engineering challenges.
- Qualifications: Engineering degree with 5-8 years in regulated product development.
- Other info: Collaborative culture with a focus on continuous improvement and technical ownership.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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.
- 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 5–8 years’ experience in R&D, NPI or design transfer within a regulated industry.
Senior NPI Project Engineer in England employer: Halian | Managed Services, Recruitment Agency & Contract Staffing
Contact Detail:
Halian | Managed Services, Recruitment Agency & Contract Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior NPI Project Engineer in England
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and don’t be shy about letting people know you’re on the hunt for a Senior NPI Project Engineer role. You never know who might have the inside scoop on an opportunity!
✨Tip Number 2
Prepare for those interviews by brushing up on your technical knowledge and project management skills. Be ready to discuss your experience with design control, risk management, and validation processes. Show them you can lead projects from concept to production with confidence!
✨Tip Number 3
Don’t forget to showcase your soft skills! Being a confident communicator is key, especially when leading technical discussions. Practice articulating your thoughts clearly and concisely, so you can impress during interviews.
✨Tip Number 4
Apply through our website! We’ve got loads of exciting opportunities waiting for you. Plus, it’s a great way to ensure your application gets seen by the right people. Let’s get you that dream job together!
We think you need these skills to ace Senior NPI Project Engineer in England
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior NPI Project Engineer role. Highlight your experience in regulated product development and any specific projects that showcase your technical ownership and cross-functional collaboration skills.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about driving innovation and how your background aligns with our needs. Don’t forget to mention your experience with design control and risk management!
Showcase Your Technical Skills: In your application, be sure to highlight your engineering background and any relevant tools you've used, like FMEA or validation processes. We want to see how you can interpret technical drawings and manage design documentation effectively.
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. Plus, it makes the process smoother for everyone!
How to prepare for a job interview at Halian | Managed Services, Recruitment Agency & Contract Staffing
✨Know Your NPI Inside Out
Make sure you’re well-versed in the new product introduction (NPI) process. Brush up on your knowledge of design transfer projects and be ready to discuss how you've led similar initiatives in the past. Highlight specific examples where you’ve driven innovation from concept to production.
✨Master the Technical Details
Since this role requires a strong engineering background, be prepared to dive deep into technical discussions. Familiarise yourself with ISO 13485, risk management, and validation processes like IQ/OQ/PQ. Bring along examples of design documentation you've produced, such as specifications or drawings, to showcase your expertise.
✨Showcase Your Communication Skills
As a confident communicator, you’ll need to lead technical discussions effectively. Practice articulating complex engineering concepts clearly and concisely. Think about how you can demonstrate your ability to collaborate cross-functionally and mentor junior engineers during the interview.
✨Prepare for Regulatory Questions
Given the regulated nature of the industry, expect questions around FDA/cGMP requirements and regulatory submissions. Be ready to discuss your experience with supplier qualification and technical audits. This will show that you understand the importance of compliance in product development.
