Process Engineer - Pilot Line Production - Bedfordshire

Ref: 488 Date Posted: Wednesday 05 Jan 2022
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The Company:

Would you like to be at the forefront of medical innovation by finding unique solutions for optimising products and processes whilst scaling a pilot line through to manufacture?

We have an exciting permanent opportunity to join a rapidly growing engineering and development company’s R&D department who specialize in POC diagnostic devices that can test for blood bourne diseases.

Our clients are industry leading innovators with a mission to transform community-based healthcare through point of care (POC) diagnostics and make lab-comparable tests accessible to all.

The Role:

Based in Bedford, you will lead a small team in the manufacturing of prototype diagnostic test strips and drive process engineering improvements across all pilot line equipment & processes. You will be responsible for the technical leadership of the team as well as the continuous development of the pilot line manufacturing.

Essential Experience:

  • Experience of working in a manufacturing/engineering role, ideally including collaboration with R&D / process development, more ideally within GMP regulated industry e.g. medical devices.  
  • Background in product/process engineering.  
  • Proven people management skills  
  • Knowledge of statistical process controls, capabilities and analysis techniques.  
  • Technical and team leadership skills.  


  • Drive pilot line manufacturing to ensure delivery against the specifications and timelines of multiple assay development projects.  
  • Establish robust Critical To Quality (CTQ) elements, implement statistical process controls and deploy across the Pilot Line; drive process, equipment & method improvements and team members to achieve CTQ targets.  
  • Develop vision inspection and other methods to inspect to CTQ’s, carry out Test Method Validations (TMVs) where needed on inspection methods to demonstrate robustness.  
  • Work with assay teams (R&D teams developing the new assays) and drive test strip design improvements into the Pilot Line  
  • Report on statistical analysis and trends.  
  • Manage and develop members of the manufacturing team such that they are motivated and developed to meet the needs of their role to reach their potential.  
  • Ensure regular scheduling and maintenance periods with the manufacturing team, to ensure manufacturing are prepared to meet the needs of the site. 
  • Manage material supplies and incoming stock management.  
  • Establish a strong working relationship with the assay teams to fully understand their needs and clearly communicate Pilot Line progress. 

Quality / Regulatory Compliance:

  • Process control and pilot line operation according to controlled processes with clear recording of outputs and deviations. 
  • Detail conscious and committed to achieving accuracy required. 
  • Ensure full compliance with all relevant GMP and HSE requirements. 


Specialists in consultancy

At Medical Engineers we have a range of technical consulting jobs in the medical engineering industry throughout the UK. Requiring a broad range of technical and management skills and most importantly the ability to communicate effectively. Consultancy roles require candidates with unique abilities. Roles vary in length of contract depending on clients’ requirements.

Our degree qualified consultants have specialist knowledge of the UK medical engineering consultancy job market. We have a successful track record in finding the best candidates for our clients who know and trust Medical Engineers to understand their business requirements.

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