Senior Process Engineer

Location

Stirling, UK

Job Type

Permanent

Company Overview

LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx currently has over 450 employees worldwide. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.

Role & Responsibilities

As a Senior Process Engineer, you will cover all aspects of the current R&D assembly process and high-speed manufacturing process, carry out device testing, process characterisation & optimisation, developing test methods, driving continuous improvement and crucially identifying which aspects of the product and process influence final device performance. Moving forward, you will be heavily involved in the scaling up of the R&D process to a high volume automated production line. As a Senior Process Engineer, you will be able to manage 5 or 6 concurrent projects.
Key Responsibilities
  • Characterisation of product and process
  • Device testing, identifying which aspects of device function are correct and which require optimisation
  • Develop robust test methods
  • Product and process performance monitoring
  • Statistical analysis and trend monitoring
  • Determine, categorise and develop mitigation for failure modes
  • Define critical design inputs to product and process designs
  • Develop & improve manufacturing methods utilising knowledge of product design, materials, fabrication processes, tooling, and production equipment assembly methods
  • Use a methodical approach to all problem solving and report progress in a structured way
  • Be open to self-development and the development of others during the transition from R&D through to volume manufacture
  • Adhere to all relevant regulatory requirements

Required Experience

Essential Skills
  • A hands on Process Engineer with a high level of relevant industry experience
  • Experience of device/product testing
  • Experience of characterising and optimising product and processes, medical would be an advantage
  • Knowledge of statistical process controls, capabilities and analysis techniques
  • Experience of developing product specifications and test method validation
  • Process validation (OQ/PQ)
  • Experience of product verification and validation, through the writing and execution of protocols
  • Experience and knowledge of Design of Experiments
  • Ability to manage external supplier/technical partners
  • Ability to take device ideas from concept through to prototype assembly and performance evaluation
  • cGMP experience
  • High level of computer literacy
  • Competent in documentation and report writing
Desirable Skills
  • Preferably Degree qualified
  • Process Excellence Green Belt or Black Belt

 

For further information and to apply for this role, please click APPLY

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Thank you for your interest. If you're successful in your application, you may be subject to all or some of the LumiraDx standard pre-employment checks. This includes employment references; Criminal records data checks which are processed as part of our recruitment process for employment or continued employment to comply with legal and regulatory obligations to which the company is subject. LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security.