NPI Engineer - Clinical Diagnostics

NPI Engineer - Clinical Diagnostics

Newton Colmore is representing a medical devices company based in Cambridge, recognised as an industry leader in novel clinical diagnostics technology. This organisation has built a strong reputation for delivering life-changing healthcare solutions through engineering and manufacturing excellence.

Due to continued growth and expansion of their product portfolio, they are seeking an experienced NPI Engineer to join their manufacturing transfer team.

The Role

This is a great opportunity for an NPI engineer to play a pivotal role in bringing innovative medical devices from concept through to commercial production. You will be at the heart of new product introduction (NPI) activities, working closely with cross-functional teams to ensure seamless product launches.

Key Responsibilities

Design for Manufacturing (DfM) & Transfer:

• Lead design for manufacturing initiatives, working collaboratively with R&D teams to improve product designs for efficient, scalable production
• Drive technology transfer activities from development through to full-scale manufacturing
• Develop and implement manufacturing strategies for new product introductions
• Conduct manufacturing feasibility assessments and risk analyses

Process Development & Optimisation:

• Design, develop and validate manufacturing processes for medical device production
• Create detailed manufacturing procedures, work instructions and quality control protocols
• Implement lean manufacturing principles and continuous improvement initiatives
• Support scale-up activities from pilot production to commercial volumes

Cross-functional Collaboration:

• Partner with quality assurance teams to ensure regulatory compliance throughout the manufacturing process
• Work closely with supply chain and procurement teams on vendor qualification and component sourcing
• Collaborate with project management teams to ensure timely delivery of NPI milestones

Essential Requirements

• Ideally around five years in manufacturing engineering within a medical devices or biotechnology environment. Flexible for the right candidate.
• Proven experience in design for manufacturing and new product introduction
• Strong knowledge of manufacturing processes including machining, assembly, and quality control systems
• Experience with manufacturing transfer projects and scale-up activities
• Understanding of medical device regulations (ISO 13485, FDA QSR, MDR) is highly desirable
• Proficiency in CAD software and manufacturing analysis tools
• Strong project management and cross-functional collaboration skills
• Ideally educated to degree level in a relevant subject.

What''s On Offer

• Competitive salary commensurate with experience - flexible from mid-level to senior.
• Comprehensive benefits package including bonus, healthcare, pension, and much more.
• Opportunity to work with complex medical technology that makes a real difference to patients
• Professional development opportunities and career progression
• Cooperative, innovative working environment with world-class engineering teams

Next Steps

This is a confidential search being conducted on behalf of our client. For a discrete, confidential discussion about this exceptional opportunity, please contact:

Matt Lowdon
Founder
(phone number removed) / hello @ newtoncolmore . com

All applications will be treated in the strictest confidence. Due to the confidential nature of this search, only shortlisted candidates will be contacted with full company details.

We are committed to equal opportunities and welcome applications from all qualified candidates regardless of background.