Overview
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. The organisation delivers life-changing healthcare solutions through engineering and manufacturing excellence. An experienced NPI Engineer is sought to join the manufacturing transfer team to expand the product portfolio.
Responsibilities
* Lead design for manufacturing (DfM) initiatives, working with R&D 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 to ensure regulatory compliance; work with supply chain and procurement on vendor qualification and sourcing; collaborate with project management to meet 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 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.
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