iFAST Diagnostics

Manufacturing Technician Location: Office based, Whiteley PO15 7AF Salary: £29,000-£33,000, depending on skills and experience Contract: Full Time, Permanent What we offer: In common with many start-ups, we offer a fast-paced, dynamic environment where you can learn a huge amount in a short time, with exposure to everything happening in the company. We look after our staff as they are our key asset, and offer regular salary reviews, share options, lots of flexibility and generous training allowances. Our facilities are commutable from most of Hampshire, West Sussex, Poole, Bournemouth etc. About the company: iFAST is an innovative new medical technology spinout from the University of Southampton, led by an experienced team of entrepreneurs and scientists. We have developed a game changing microfluidics based test for antimicrobial susceptibility, reducing the test time from 48+ to 3 hours to help combat the global threat of antimicrobial resistance, which kills more than 1 million people per year. Job Role: We are now seeking a manufacturing technician to join our team in Whiteley, Hampshire, reporting to our Head of Manufacturing Operations, to help us build our instruments and manufacture our microfluidic chips to bring our technology to market. Responsibilities: Manufacturing: • Manufacturing of microfluidic chips and iFAST instruments in accordance with written instructions • Perform complex, detailed operations on small parts, working under a microscope where necessary • Keep accurate, clear manufacturing records and maintain clean, organised work area • Comply with work instructions, guidelines and regulatory requirements • Report problems (and potential problems) with quality, processes, equipment and materials to management • Ensure all equipment used is appropriately cleaned, maintained, calibrated before use Design & Development: • Assist with product development by assembling prototype devices and providing feedback • Perform product testing to provide information on product performance • Keep accurate, clear and complete records for inclusion within the Design History File • Writing new work instructions and process flow cards Quality System: • Work within medical device quality system in accordance with EN ISO 13485:2016 and 21 CFR 820 • Responsible for operating and maintaining the manufacturing laboratory equipment as specified by the relevant SOPs • Input into product quality meetings, offer ideas and corrective actions Support: • Provide technical support to Quality (e.g. training, input into non-conformance investigations, customer complaints) • Assist with documentation in accordance with standards, manufacturing procedure documentation, and SOPs. • Provide feedback and support for continuous improvement projects • Periodically presenting your work to the team and our collaborators, and performing other tasks as assigned Knowledge, Skills & Experience: • Good numeracy and basic IT skills; ability to work in accordance with documented work instructions • Appropriate engineering or medical devices experience working to ISO 13485 or GLP • Excellent practical skills with experience using precision manufacturing equipment • Experience of working within a controlled environment, such as a GLP laboratory or cleanroom • Familiarity with wiring, cable harnesses, crimping and soldering is desirable but not essential • The ability to work well in a team and to manage & prioritize your own workload with minimal supervision • Great interpersonal skills, as we are a small, close-knit team with a culture of togetherness • Good problem-solving skills and the ability to use your initiative to fix things when they go wrong • An accurate and methodical approach to work, including documentation in compliant with our QMS • Being a self-starter you should have great self-motivation to do a great job and to help the company succeed • Excellent attention to detail including reading CAD drawings If you feel you have the necessary skills and experience to be successful in this role, click on APPLY today, forwarding an up-to-date copy of your CV for consideration in the first instance. No agencies please.

Junior Software Engineer Location: Office based, Whiteley PO15 7AF Salary: Competitive, depending on experience Contract: Full Time, Permanent Benefits: 27 days holiday (increasing 1 day each year), Flexible working hours, Share options, Company pension, Cycle to Work Scheme, Private Dental care About the company: iFAST Diagnostics is a medical device company that has developed a game-changing, rapid antimicrobial susceptibility test, that will enable the right antibiotic treatment for all patients with bacterial infections. Currently, these tests take 48-72 hours, but iFAST's tests are 10x faster giving full quantitative and qualitative results in under 3 hours from a positive blood culture or bacterial isolate. Job Role: We are seeking a Software Engineer or Computer Scientist to join our team as we roll out our instruments in the UK, having just received our UKCA approval for the first product. You will design, implement and test a variety of software including middleware, firmware and algorithm development which are integral to our novel medical diagnostic product Responsibilities: • Development of software for our current and future instruments, including algorithm development, processing code and middleware. • Writing code and algorithms in accordance with good Software practise Experience of relevant standards and medical device regulations would be beneficial (e.g. ISO 13485, ISO 9001 ISO 14971 and IEC 62304.) • Development of test plans and procedures, conducting and accurately documenting the tests at unit, sub-system and system level. • Working closely with internal and external stakeholders e.g. production, service, sales teams and suppliers. Knowledge, Skills & Experience: • Have experience of software development for medical devices or similar within an ISO regulated environment and be able to work to associated regulations such as IEC 62304. • Be able to work efficiently with source code management tools. • Be familiar with IEC 62304 compliant software development processes and standards to produce well documented, maintainable, and test-driven code. • Understand machine learning concepts and be able to choose appropriate techniques for a given task and dataset, including supervised learning. • Have a strong mathematical and statistical background and be able to apply this to algorithm development. • Have experience of writing software for controlling electromechanical equipment, ideally in C/C++, Python, MATLAB or PLC code. • Hold a (first or 2:1) degree in a relevant discipline. • Need to be able to work under minimal supervision with a flexible attitude and be capable of solving problems and working to an agreed timescale to deliver on your projects. If you feel you have the necessary skills and experience to be successful in this role, click on APPLY today, forwarding an up-to-date copy of your CV for consideration in the first instance. No agencies please.