Tyne and Wear
£35,000 – £45,000
Key Roles & Responsibilities
The candidate hired for this role will work within a team of scientists and engineers developing portable molecular diagnostic device and molecular diagnostics assays for a range of diseases.
They will be competent to take a lead technical role in the mechanical design of devices.
The candidate will also be required to not only work within and ensure excellent communication with the development team, but also work as part of a wider research group, with other laboratories and partners globally.
Adhere to all of Quality Assurance (QA) Systems.
Experience, knowledge and requirements
• The candidate hired for this role will be an extraordinary individual who has strong technical understanding and experience in engineering design for life science instrumentation and microfluidics, and a proven ability to work within a multi-disciplinary team of scientists and engineers to accomplish product development goals.
• Experience with a 3D CAD system, preferably SolidWorks v2017
• Experience of calculations software, eg Mathcad
• Experience of 2D CAD software, ideally AutoCAD
• Understanding of the dimensioning, tolerancing and surface characteristics necessary for microfluidics.
• Knowledge of techniques for design for manufacture, assembly and maintenance.
• Ability to source suitable components and manufacturers and manage those outsourcing projects.
• Understanding of appropriate manufacturing processes.
• Excellent communication skills and ability to work in a changing environment on complex projects.
• Outstanding teamwork and an ability to interact with external and internal partners on fast-paced projects.
• Minimum 5 years relevant experience working in product engineering with experience of life science instrumentation, 10 years’ experience from an alternative industry.
• MEng or equivalent in Mechanical Engineering or similar.
• Achieved, or working towards Charted Mechanical Engineer status
• Understanding of materials for microfluidics.
• Good sense of humour, team player and an ability to adapt to a rapidly changing environment as the company matures and moves from the R&D stage into commercialisation.
• Experience of running projects and supervising other engineers
• Be eligible to work full time in the UK without restriction.
• Practical engineering workshop skills
• Experience with flow and thermal simulation.
• Experience with microfluidics
• Experience in developing design history files to ISO standards including ISO9001 and IS013485 for CEIVD and FDA requirements.
• Familiarity with global regulatory requirements that pertain to product development and in vitro device manufacturing (e.g. CE IVD mark, FDA, etc).
• Understanding of electronics including interpreting PCB designs diagrams and schematics, component recognition, electrical safety and electrical assembly skills including PCB assembling and wiring