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Head of Product Technology - Digital Diagnostics

Job LocationCambridge
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

TEC Partners are recruiting for a high-growth, digital in-vitro diagnostic start-up who are looking for a Head of Product to join their expanding team in Cambridge. You will be responsible for transitioning products from R&D through to production and launch,whilst managing the laboratory operations at their ISO13485 regulated lab in Cambridge.You will be an integral member of the executive management team working closely with the CEO to plan manufacturing strategy, operations and drive company growth. This will involve working in a fast-paced dynamic environment focused around medical devicetechnology.Head of Product Key Responsibilities:

  • Manage the laboratory operations in line with ISO13485
  • Manage a small team of production scientists
  • Responsible for the technology transfer of production from R&D to production
  • Responsible for supply chains and manufacturing
  • Responsible for the completion of raw material specifications, in-process and out-sourced QC documentation and verification / validation processes in partnership with QA/RA director
  • Ensure compliance of laboratory with ISO13485
  • Own the companys manufacturing strategy and plan
  • Responsible for scaling prototypes to higher launch volumes
  • P&L responsibility for manufacturing function
  • Monitor the industry landscape with a particular focus on incremental innovations applicable to our products
  • Responsible for the life-cycle management of existing product
Head of Product Qualifications & Experience required:
  • Minimum 10 years experience working in manufacturing within diagnostic or medical device companies
  • Minimum 5 years management experience, ideally managing a commercial laboratory
  • Proficiency in quality systems (ISO 13485), associated documentation and processes
  • Excellent knowledge of the in-vitro diagnostic industry and regulations (IVDD and IVDR)
  • Experience in tech transfer from R&D setting
  • Experience in establishing and managing supply chains
  • Experience in lateral flow device manufacturing a plus
  • Experience of software as a medical device (SAMD) a plus
  • Background in chemistry, particularly surface chemistry, a plus
  • Strong communication skills
  • Passionate about technology, healthcare and entrepreneurship
  • Experienced in working in cross-functional teams
  • Driven, motivated and organised
  • Working independently with a high level of accountability
This is a great opportunity to join a company who are revolutionising the digital diagnostics space, and this particular role will be coming in at a high level to directly manage and influence the launch of their product and the subsequent successes thatwill follow.If this sounds like a challenge you are interested in, then please apply right away with an updated CV.

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