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.
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.
- 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.
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
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