Sense Biodetection: Process Engineer - IVD

Company
Sense is a start-up in vitro diagnostics company based in Cambridge and Oxford UK. The company is developing a new class of molecular diagnostic test device for a range of clinical applications.

Founded by an experienced and highly successful leadership team, Sense has ambitious plans to grow from its strong foundations and become a leader in the field. The company has significant backing from leading venture capitalist investors and is currently industrialising its first commercial products internally whilst also working with customers to develop other bespoke products.

Opportunity
This is a full-time role based at the company’s Cambridge facility reporting directly to the Director of Manufacturing and Operations. A key deliverable of the role is to drive the development and implementation of product realisation processes in support of all product industrialisation projects, on-site bio-chemical production, and commercial manufacture and supply of simple electro-mechanical devices through third party, contract manufacturing organisations. This is an exciting opportunity to be involved in helping to develop impactful diagnostic products while supporting the wider growth of a dynamic organisation.

Ideal Candidate
The ideal candidate will have experience in developing and optimising processes and systems to support the transition of products from early development to routine, commercial production. They will be experienced in the preparation of clear, concise, and comprehensive equipment URS’s and process validation schemes, with the ability to execute on these either individually or as part of a cross-functional team. They will have undertaken, and possibly led, process focussed risk analysis for product design and product assembly. They will also be able to demonstrate a good understanding of manual, semi-automated and automated manufacturing processes, calculation of equipment cycle-times and equipment costs The ideal candidate will be hands-on and flexible to taking on a variety of tasks as is typical in a small organisation

Skills
• Demonstrable experience of working in a regulated process/manufacturing environment, ideally with Medical Device products
• Excellent communication skills at all levels
• High standard of written English
• Experienced in the use of relevant software

Start: Immediate
Salary: Competitive, depends on experience - +pension +bonus +share options