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Job Purpose Atlas is seeking to identify an experienced manufacturing process engineer with either a mechanical, electrical or physics background to be Atlas technical lead for the development of disposable IVD cartridge manufacture (manual, semi-auto and fully integrated automatic lines). The primary responsibility will be to act as technical interface and project leader for our cartridge manufacture in liaison with our contracted third party who have a 7 strong team working on the manufacturing development project. The role reports directly to the Atlas Operations Director and will require regular travel within the UK. Key Responsibilities * Successful development of a fully validate cartridge assembly process within agreed budget and timeline * Represent Atlas at weekly face to face and/or telecons with contract manufacturing organisation(s) to discuss project progress against agree timelines * Assist in creation, review and update of work charters and project plans * Technically support in-process test method development * Input to process validation strategy * Ensure manufacturing development approaches are in line with IVD regulatory requirements Key Skills * Degree or equivalent in mechanical engineering, electrical engineering or physics * At least 5 years hands-on within a medical manufacturing environment * IVD/medical device semi-automatic/fully automatic manufacturing * Operating to Quality Management & Regulatory frameworks relevant to IVD/medical devices * Process validation * Laser bonding techniques * Heat sealing * Liquid dispensing * Liquid drying * Seal strength testing * Leak testing * Visual inspection systems * Blister form, fill, seal * Label printing and application * Final packaging * Batch release * Storage and handling * Leading projects * Operating within multi-company matrix * Technical and progress data presentation * Strong verbal & written communication * Comfortable working with Senior Management * Willing to ask questions and challenge proposals Company Information Atlas Genetics Ltd is a rapidly growing in vitro diagnostics company that is seeking to expand its commercial development activities by recruiting highly experienced and talented individuals who, through initiative and self-motivation, can drive the company to meet its ambitious targets. Based in modern custom built laboratories in Trowbridge, near Bath, Atlas Genetics is developing the next generation Point-of-Care diagnostic platform incorporating both nucleic acid and immunoassay technologies. This system, initially targeting infectious diseases, will revolutionise patient diagnosis, providing ultra-rapid, laboratory-quality tests to clinics and doctor's offices, allowing a single appointment, 'test & treat' approach for many diseases. Atlas Genetics is a young, dynamic company, working in one of the most cutting-edge areas in medical diagnostics. Employees should have a flexible and energetic working style, where proactive input from all is encouraged and employee-led initiatives are welcomed. Please note it is unlawful to employ a person in a UK-based job who does not have permission to live and work in the UK. You should make yourself aware of how immigration laws apply to your situation before applying for any jobs. Please refer to the Home Office website before applying. Atlas Genetics Ltd is an equal opportunities employer. To apply please click the 'Apply Now' button below. manufacturing process engineer quality management regulatory laser bonding techniques mechanical electrical or physics background
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