NPI Engineer - Clinical Diagnostics

NPI Engineer – Clinical Diagnostics\\n\\nNewton 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.\\n\\nDue to continued growth and expansion of their product portfolio, they are seeking an experienced NPI Engineer to join their manufacturing transfer team.\\n\\nThe Role\\n\\nThis 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.\\n\\nKey Responsibilities\\n\\nDesign for Manufacturing (DfM) & Transfer:\\n\\nLead design for manufacturing initiatives, working collaboratively with R&D teams to improve product designs for efficient, scalable production\\nDrive technology transfer activities from development through to full-scale manufacturing\\nDevelop and implement manufacturing strategies for new product introductions\\nConduct manufacturing feasibility assessments and risk analysesProcess Development & Optimisation:\\n\\nDesign, develop and validate manufacturing processes for medical device production\\nCreate detailed manufacturing procedures, work instructions and quality control protocols\\nImplement lean manufacturing principles and continuous improvement initiatives\\nSupport scale-up activities from pilot production to commercial volumesCross-functional Collaboration:\\n\\nPartner with quality assurance teams to ensure regulatory compliance throughout the manufacturing process\\nWork closely with supply chain and procurement teams on vendor qualification and component sourcing\\nCollaborate with project management teams to ensure timely delivery of NPI milestones \\n\\nEssential Requirements\\n\\nIdeally around five years in manufacturing engineering within a medical devices or biotechnology environment.

Flexible for the right candidate.\\nProven experience in design for manufacturing and new product introduction\\nStrong knowledge of manufacturing processes including machining, assembly, and quality control systems\\nExperience with manufacturing transfer projects and scale-up activities\\nUnderstanding of medical device regulations (ISO 13485, FDA QSR, MDR) is highly desirable\\nProficiency in CAD software and manufacturing analysis tools\\nStrong project management and cross-functional collaboration skills\\nIdeally educated to degree level in a relevant subject. \\n\\nWhat's On Offer\\n\\nCompetitive salary commensurate with experience – flexible from mid-level to senior.\\nComprehensive benefits package including bonus, healthcare, pension, and much more.\\nOpportunity to work with complex medical technology that makes a real difference to patients\\nProfessional development opportunities and career progression\\nCooperative, innovative working environment with world-class engineering teamsNext Steps\\n\\nThis is a confidential search being conducted on behalf of our client. For a discrete, confidential discussion about this exceptional opportunity, please contact:\\n\\nMatt Lowdon\\n Founder\\n (phone number removed) / hello @ newtoncolmore .

com \\n\\nAll 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.\\n\\nWe are committed to equal opportunities and welcome applications from all qualified candidates regardless of background