The Process Engineer will be based in S. Yorkshire and be involved in all aspects of daily manufacture (e.g. line operation, processes and procedures) whilst executing product and process validation and verification - including IQ,OQ,PQ,DOE and support completion of validation documentation.Client Details
Our client, LumiraDx, design and develop smarter solutions to help meet the global challenge of delivering more effective, cost-efficient healthcare for everyone.
They are a dynamic, fast-growing business with a team of talented, passionate and creative people.
We are partnering exclusively with them to recruit across the business as they grow to meet demand in these unprecedented times. We are looking for flexible, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of this forward-looking business.
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.
LumiraDx is rapidly expanding and currently has over 1200 employees worldwide.Description
You will be based in S. Yorkshire and 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 completion of documentation. Identify / implement new process improvements and quality controls. Act as engineering technical lead by supporting 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-conformance's 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 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 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.
Overview of Essential and Desirable knowledge, skills and required to be successful in the Process Engineer role:
- Experience of optimising product and processes within industry (preferably medical device)
- Process Excellence Green or Black Belt
- Demonstrates excellent problem-solving skills (e.g. thinking critically to make key decisions under pressure)
- Preferably Degree qualified
- Understanding of lean manufacturing principles and statistical analysis methods / techniques
- Experience in rotary converting and / or reel to reel printing (rotary screen / flexographic etc.) additional advantage
- Proficient in use of MS Office, Powerpoint, data analysis software (e.g. Minitab, Excel) and CAD software
- Understanding of ISO 13485 relating to manufacturing, other regulations and standards would be an advantage.
- Lead and execute validation and verification activities and ensures timely completion of associated documentation
- Experience in mentoring / training work colleagues to aid professional development and drive manufacturing excellence
- Drives improvements to manufacturing productivity and quality through engagement / training of production team
- Technical engineering lead for process and product issues and ensures fast and effective closure of quality events / non-conformances
- Ensures highest standards of quality and compliance 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
The Process Engineer will get:
- Excellent salary and great benefits package (including free employee COVID testing on site).
- Please note, if you wish to submit an application for this role, please consider the following information:
- PageGroup are our exclusive recruitment partner for this vacancy and all applications, whether internal or external, will be forwarded to them.
- If you're successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.