Process Enhancement Lead

2 weeks ago


Cambridge, Cambridgeshire, United Kingdom TEC Partners - Technical Recruitment Specialists Full time

Job Overview

This exciting role offers the opportunity to contribute to groundbreaking work in Point of Care (PoC) diagnostics, focused on making healthcare more accessible and effective.

You will work closely with cross-functional teams to develop new methodologies or technologies for product/process improvement, ensuring compliance with relevant industry standards (e.g., ISO 13485, IVDD/IVDR).

Main Responsibilities:

  • Analyze current processes to identify areas for improvement.
  • Evaluate and enhance product performance and quality.
  • Develop new methodologies or technologies for product/process improvement.
  • Collect and analyze data to support decision-making and track performance.
  • Collaborate with engineering, manufacturing, and marketing teams to implement improvements.
  • Design and execute experiments to test new processes or product modifications.
  • Maintain detailed records of methodologies and findings.
  • Train teams on new processes or product changes.
  • Ensure compliance with relevant industry standards (e.g., ISO 13485, IVDD/IVDR).
  • Foster ongoing enhancement through leading or participating in projects.

Requirements:

  • Bachelor's degree in Chemistry or Life Science-related discipline.
  • 5+ years' experience in lateral flow device manufacturing or diagnostics/medical device field.
  • 3+ years' experience in tech transfer from R&D.
  • Expertise in microfluidics, immunoassays, and colorimetric sensing systems.
  • Hands-on experience working with biomolecules (proteins, antibodies, metabolites).
  • Proficiency in quality systems (ISO 13485) and knowledge of in-vitro diagnostic regulations (IVDD, IVDR).
  • Strong communication skills and experience in cross-functional team settings.
  • Motivated, organized, and capable of working independently with high accountability.

Annual Salary: £70,000 based on experience and qualifications.


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