Join our cutting-edge diagnostics engineering team and drive the development of world-class medical technology. If you're passionate about product design, compliance, and bringing ideas to life, this is the role for you!Senior Product EngineerManchester, M13 9XXFull time, permanentUp to £65,000 per annumPlease Note: Applicants must be authorised to work in the UKGenedrive Diagnostics is at the forefront of medical diagnostics, developing innovative solutions to revolutionise patient care. We specialise in advanced molecular diagnostic technologies, ensuring high-performance, reliable, and accessible healthcare solutions worldwide. As part of our dynamic engineering team, you'll be instrumental in designing, developing, and launching cutting-edge medical devices.The RoleAs a Senior/Principal Electronics & Product Engineer , you will take a leading role in the development and release of the Genedrive system. Working closely with cross-functional teams, you'll drive innovation, ensuring compliance, functionality, and manufacturability of our next-generation diagnostic devices.Key Responsibilities:Act as a lead engineer for a IVD electronics productsLead design of our instrumentation, from concept, through manufacturing up to registration with the regulatorLead compliance approvals for FCC, EMC, CE, UKCA, CB Scheme, FDAConduct hardware verification, validation, and root cause analysisSupport software teams with hardware integrationCollaborate with suppliers and partners to ensure high-quality product developmentDrive research and development for hardware, consumable design, and ancillary equipment/softwareManage full product lifecycle maintenance and improvementSupport manufacturing and technical service functionsPrepare and maintain technical documentation, work instructions, and operating proceduresBenefitsWe offer a competitive salary, along with a supportive and collaborative work environment where your expertise will shape the future of diagnostics technology. Additional benefits include:Career Growth – Progression opportunities within a pioneering medical tech companyHealthcare & wellbeing - Applicable cover from day one under our private healthcare policyInnovative Projects – Work on industry-changing productsSupportive Team Culture – Be part of a team that values collaboration and innovationThe Ideal CandidateYou're a self-driven, experienced engineer who thrives in an innovative environment. You have a strong background in product design and development, particularly in medical or highly regulated industries. About you:5+ years' experience in end-to-end product design, from concept to manufacturingStrong knowledge of electronic design for compliance & regulatory approvalsExpertise in IVD/medical device compliance (EU & USA)Experience in regulated product development (ISO 13485, IVDR, 60601, EMC standards, FDA approvals) is desirableHands-on experience with microprocessor-controlled electronics & embedded softwareProficiency in Altium or similar schematic capture toolsExperience in optoelectronics, PID temperature control, and reliability testingAbility to lead projects and manage multiple workstreamsStrong communication & problem-solving skillsBackground in small company environment is desirableIf you're ready to make a real impact, apply today!How to apply for the role:If you have the skills and experience required for this position, click “apply” today and check your inbox for an email providing more information on how to tailor your application and provide a cover letter or any supporting documents.You must be authorised to work in the UK. No agencies please.Closing Date: 19th March 2025Other suitable skills and experience include Electronics Engineer, Systems Engineer, Hardware Engineer, Product Development Engineer, Medical Device Engineer, Embedded Systems Engineer, Compliance Engineer, Electrical Engineer, R&D Engineer, Mechatronics Engineer.TPBN1_UKTJ