Field Service Engineer

Field Service Engineer – Medical Devices - Involves extensive travel within the UK, EU, Middle East, and other global locations.Our client a Leading Medical Device Manufacturer is looking to appoint an experienced Field Service Engineer who will be required to travel to customers in the EU, UK and Middle East to support their Operations team by performing product installations, maintenance and repairs of one of their devices.The position focuses on delivering exceptional customer support through on-site visits, phone, and email, ensuring a seamless experience for clients.Operating within the Quality Management System, you will log and track complaints, assist with root cause analysis, and drive timely resolutions to support continuous product improvement.When time allows, you will also contribute to on-site activities, including production and stock control of handheld devices. Key requirements of the role.Able to work independently, perform and manage multiple activities relating to medical device manufacturing and servicing under general direction.Ability to work in a team setting within a matrix management structure.Able to follow technical and procedural documentation in line with the requirements of Quality, Regulatory Management system and applicable standards relating to the activities of our clients business and legal requirements.Able to commit to and comply with GMP, GDP, FDA 820, ISO 13485 and H&S requirements as directed by the requirements of the Quality Management System and associated processes and procedures.Participate in internal and external audits as required.Able to record, complete and maintain documentation and electronic records with a high level of accuracy and attention to detail.Able to identify and contribute to Non-Conformities and CAPA activities as required, within the Quality Management System.Able to read and interpret technical drawings (e.g. mechanical, wiring diagrams etc.)Working knowledge of mechanical and power hand tools (e.g., torque wrench/driver, drill, wire stripper/crimper).Strong electrical diagnostics, discharge (ESD) and troubleshooting knowledge including use of electrical test equipment and safety equipment.Able to work with infrared/laser radiation output sources with proper PPEPhysical capability to lift up to 25 kgs and handle equipment safelyWillingness to embody the company values and culture Field and Customer Support Travel to customer sites as required to troubleshoot, perform repairs (both warranty and non-warranty) or upgrades to specification, documenting findings and communicating outcomes using the correct processes for trend analysis.Investigate customer complaints and field-performance issues using structured problem-solving methods to determine root cause and implement corrective actions.Provide feedback on recurring field issues, and collaborate with engineering teams to implement durable corrective measures, and monitor effectiveness.Timely and accurate submittal of administrative duties including but not limited to; work orders, field service forms, expense reports and timesheets.Provide field feedback both from the customer and your experience for new product development projects.Work with Manufacturing and Design Teams to identify opportunities for re-design or design of equipment, tools, and fixtures to improve manufacturing processes, and reduce risk and scrap.Comply with Quality, GMP, ISO and safety regulations at all time.Perform additional duties as needed and/or assigned by supervisor/manager. Head Office – Production Team Assemble components accurately, thoroughly and quickly to approved specificationsProduction of tested, excellent quality assemblies for use as finished goodsTo be proficient in the testing, manufacture and repair of Company productsAssist with stock cycle counts and picking of components for assemblyConserve resources and supplies to facilitate minimum wasteAssist with the day to day smooth running of the manufacturing production departmentReport on issues, malfunctions or defective partsAssist in the design and development of products as requiredAttend team meetings to discuss manufacturing issues and suggestions for improvement Qualifications HND in Engineering or above5+ years experience in the Medical Device or equivalent industryA level Maths and English Skills: Strong mechanical/electrical diagnostic abilityProficiency in reading engineering drawings and SOPsFamiliarity with Quality Management Systems – ie root-cause analysis, CAPA, and quality auditingExperience with IEC 60601, ISO 13485, and FDA 21 CFR 820ERP experienceExcellent communication, documentation, and teamwork skills