To be part of a dynamic, fast-growing business. Rapidly expanding business which currently has over 1200 employees worldwide. 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
As the Process Engineering Manager, you will work in collaboration with Science, Reagents, Pilot Line, Instrumentation, Equipment, QA, QC and Suppliers to develop new and innovative products. You will lead a team covering all test strip design phases from feasibility through to volume manufacture, with strong focus on Design for Manufacture (DFM).
As the Process Engineering Manager you will drive all aspects of the strip design and development process from raw material sourcing, through printing, assembly and product performance evaluation. You will carry out product development, characterisation & optimisation, while developing test methods, driving continuous improvement and crucially identifying which aspects of the product features or quality elements influence the final device performance. You will be able to manage several projects concurrently and manage a team consisting of 4 or more Process Engineers, ensuring delivery on all team goals.Key Areas of Responsibility:Technical
- Manage a team of 4 Process Engineers to deliver on related goals.
- Develop new products that prove to be robust & efficient. Manage several projects concurrently.
- Product Characterisation.
- Ensure all product Critical To Quality (CTQ) targets are met. Drive improvements as necessary.
- Drive Cost Of Goods (COGs) reduction program and necessary re-validation activities.
- Test Method development and validation.
- Product performance monitoring.
- Statistical analysis and trend monitoring.
- Determine, categorise and develop mitigation for failure modes.
- Define critical inputs to products.
- 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.
- Transition product from R&D through to volume manufacture.
- Adhere to all relevant regulatory requirements.
- Manage external supplier/technical partners.
Communication & Collaboration:
- Investigate, root cause & resolve Non-Conformances / Quality Events.
- Ensure changes to product and specifications meet quality standards and are documented appropriately.
- Company wide collaboration across all disciplines.
- Build strong relationships with suppliers.
- Working with manufacturing teams to ensure methods are appropriate and meet requirements.
- A hands-on Engineer with a high level of relevant industry experience
- Experienced in product characterisation / optimisation
- Experienced in statistical analysis techniques
- Experience in Test Method Validation
- Experience in product and process validation.
- Experience in Design of Experiments
- cGMP experience
- cGLP experience
- High level of computer literacy in MS Office
- Competent in documentation and report writing
- Process Excellence Green or Black Belt
- Degree qualified
- Corel Draw
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.