Company Overview
Sapphiros is dedicated to revolutionizing healthcare diagnostics by providing reliable, affordable, and accessible testing solutions to communities worldwide. With cutting-edge technology and a robust manufacturing capacity, we develop innovative molecular diagnostics, point-of-care devices, and consumer health products that empower individuals to take control of their health and improve global health outcomes.
Job Overview
We're looking for a Senior Product Development Engineer (Mechanical) to take a leading role in mechanical and fluidic engineering of our diagnostic platform technologies. You'll work across the full product development lifecycle — from concept and CAD design through prototyping, verification & validation (V&V), design transfer and manufacturing scale-up — helping take our platform from grant-funded R&D through to a robust, manufacturable, regulated medical device. This is a hands-on, cross-functional role: you'll be designing and testing mechanical and fluidic components, building test rigs and jigs, writing and executing protocols under design control, and working closely with electronics, firmware, and regulatory colleagues to solve problems that sit at the interface of mechanical, fluidic and electronic design.
Duties
- Lead mechanical and fluidic design of diagnostic cartridge and instrument components — including microfluidic flow paths, valves/gates, seals, and consumable-instrument interfaces — using SolidWorks and PDM.
- Design, build and use custom test rigs and jigs to characterise mechanical and fluidic performance (e.g. flow rate, actuation force, seal integrity) and translate results into design improvements.
- Drive verification & validation (V&V) activities for current and upcoming products: write and execute test protocols, analyse results, and produce clear, well-documented reports.
- Work under formal design controls: author and maintain DHF documentation, risk analyses (DFMEA/PFMEA), and design history records in line with ISO 13485 and IEC 60601.
- Investigate and resolve mechanical/fluidic failure modes during development and build campaigns, using structured root-cause analysis and data-driven decision-making.
- Collaborate closely with electronics, firmware, optical/signal-processing and software colleagues, since mechanical, fluidic, thermal and electronic design choices are tightly coupled in our platform.
- Support design-for-manufacture (DFM) and design transfer as the product scales from bench-built prototypes to volume manufacturing, including supplier and tooling input.
Skills
- Hands-on product development experience, ideally including regulated environments — medical devices/IVD preferred, but candidates from other well-regulated sectors (aerospace, automotive, pharma equipment, etc.) will be considered.
- Degree in Mechanical Engineering (or closely related discipline), or equivalent experience
- Strong CAD skills, ideally SolidWorks, with practical experience of PDM systems.
- Demonstrable experience designing, building and testing mechanical or fluidic prototypes, rigs and/or devices, with a genuine hands-on, get-it-built attitude.
- Experience of test engineering and V&V: designing test methods, executing protocols, and documenting results to a high standard.
- Working understanding of design controls, regulatory requirements and QMS (ISO 13485, IEC 60601, IVDR/FDA) — or a strong willingness to learn them quickly.
- Comfortable working in a small, cross-functional team where mechanical decisions constantly intersect with electronics, fluidics, firmware and manufacturing.
- Excellent problem-solving skills, attention to detail, and clear written and verbal communication.
Join us at Sapphiros where your innovation fuels the future of healthcare diagnostics. We are committed to fostering a vibrant environment that supports your growth while making a meaningful impact on global health outcomes through cutting-edge technology development.
Pay: £60,000.00-£65,000.00 per year
Benefits:
- Company events
- Company pension
- Employee discount
- Enhanced maternity leave
- Financial planning services
- Free flu jabs
- Free parking
- Life insurance
- On-site gym
- On-site parking
- Private medical insurance
- Referral programme
- Sick pay
- Transport links
Application question(s):
- Please describe your experience using SolidWorks for mechanical/product design, including the types of components or products you have designed and your level of responsibility.
- Have you worked in medical device sector under ISO 13485
Experience:
- hands-on product development: 5 years (required)
Work Location: In person
