Process Engineer Manufacturing

Location

Alloa, 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 is a high growth organisation. 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

Process Engineer - Manufacturing, this role will be based across our sites in Alloa and Motherwell

This is a normal days role - Monday to Friday 08:30 to 17:30.

The Opportunity

An experienced Process Engineer who can make a significant contribution to the continued growth and success of our company.  As a Process Engineer, you will have a strong understanding of all aspects of daily manufacture.  Experienced in executing validation and verification activities and support the completion of documentation. Identify/implement new process improvements and quality controls.  Act as engineering technical lead by supporting the production team with product/process issues and NPD projects. Support and coordinate training of the production teams to implement new procedures/processes to drive manufacturing excellence. Characterise new processes/products and have a sound understanding of product and process CTQs. Demonstrate excellent problem-solving skills and be able to think critically and make key decisions under pressure. Investigate and ensure effective closure of quality events/non-conformances.

The Role

  • As a Process Engineer, you will be experienced in all aspects of daily manufacture (e.g. line operation, processes and procedures).
  • Execute Product and Process validation and verification – including IQ,OQ,PQ,DOE and support completion of validation documentation
  • Identify process problems and non-conformances in manufacturing processes and develop corrective actions
  • Good understanding of pilot manufacturing process and competent in operating pilot equipment
  • Support production team in product/process issues
  • Coordinate training of production team members to drive manufacturing excellence
  • Act as a mentor and technical resource to aid professional development
  • Support CTQ testing and deliver new material/product analysis techniques
  • Act as engineering technical lead for NPD projects and ensure successful completion of deliverables
  • Excellent understanding of product and process CTQs
  • Supports characterisation of processes/products (e.g. through the design of experiments, test method development)
  • Develop and implement new methods/software for statistical analysis, trend monitoring and reporting
  • Investigate and ensure effective closure of quality events / non-conformances
  • Proficient in updating/developing new product design features using CAD (Computer-Aided Design) software
  • Be open to self-development and training opportunities to enhance your professional skillset
  • Investigate, root cause, and resolve non-conformances / quality events.
  • Ensure changes to process and specifications meet quality standards and are documented appropriately.
  • Adhere to all relevant quality and regulatory requirements.

Required Experience

About You

We are looking for a highly self-motivated individual with a high level of skills in problem solving, along with the following skills and experience:

  • Experience in optimising products and processes within industry (preferably medical devices)
  • Demonstrates excellent problem-solving skills (e.g. thinking critically to make key decisions under pressure)
  • Understanding of lean manufacturing principles and statistical analysis methods/techniques
  • Proficient in the use of MS Office, Powerpoint, data analysis software (e.g. Minitab, Excel) and CAD software
  • Lead and execute validation and verification activities and ensures timely completion of associated documentation
  • Drives improvements to manufacturing productivity and quality through engagement/training of the production team
  • Technical engineering lead for process and product issues and ensures fast and effective closure of quality events / non-conformances
  • Ensures the highest standards of quality and compliance are maintained at all times
  • Excellent understanding of process and product characterisation methods and CTQs
  • GxP experience
  • Competent in documentation writing and presenting to key stakeholders

 

To apply for this vacancy, 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.