Resonant Inc.
Medical Device SME (Subject Matter Expert) Technical Support & Service Engineer

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Medical Device SME (Subject Matter Expert) Technical Support & Service Engineer
Job Description Summary Who We Are & What We Do We are a global life sciences solutions provider, delivering agile clinical trial and diagnostic services that help our customers navigate the complexities of life‑changing innovation. With over 40 years of experience in custom kitting and clinical trial support, our Clinical Services team combines deep technical and regulatory expertise with a strong track record of delivering high‑quality products and tailored solutions that our customers trust. Based in Chorley, our Equipment & Ancillaries team provides a truly global service, sourcing and supplying medical and laboratory equipment to meet the unique needs of each study. From single-site trials to complex, multi-country programmes, we ensure our customers have the right equipment, in the right place, at the right time, enabling them to focus on delivering successful clinical outcomes, wherever their trials take place. How will you make an impact & Requirement Role Mission As a Medical Device SME – Technical Support & Service Engineer, you will provide advanced technical expertise and leadership across laboratory and refrigeration equipment within the In-House Engineering (IHE) function. You will be responsible for ensuring the reliability, performance, and compliance of critical clinical trial equipment throughout its full lifecycle. You will act as a trusted technical authority, supporting global clinical operations by delivering high-quality service, driving continuous improvement, and ensuring adherence to regulatory standards—ultimately contributing to patient safety and data integrity. Key Responsibilities Act as the Subject Matter Expert (SME) for medical, laboratory, and refrigeration equipment, including cold-chain systems and temperature-controlled devices Deliver expert-level technical support, troubleshooting, and repair across a wide range of equipment (e.g. freezers, incubators, centrifuges, balances, monitoring systems) Perform and oversee installation, commissioning, calibration, preventative maintenance, and corrective servicing Lead ISO 17025-aligned calibration activities, including IQ/OQ/PQ documentation and compliance Support and coordinate daily workshop operations, including planning, prioritisation, and workflow optimisation Lead team huddles and contribute to delivery against OTIF and operational KPIs Maintain accurate and compliant service records, calibration certificates, and ERP system data Act as a key technical contact during audits, inspections, and regulatory reviews Conduct root cause analysis and implement sustainable corrective actions for recurring technical issues Coordinate and oversee external vendors and subcontractors, ensuring service quality and compliance Respond to technical escalations, customer enquiries, equipment recalls, and product alerts Provide input into product lifecycle management, including evaluation, upgrades, and equipment selection Act as the Health & Safety and COSHH lead within IHE, ensuring safe systems of work and compliance Mentor and develop engineers, sharing knowledge and building technical capability across the team Drive continuous improvement initiatives across processes, performance, and service delivery What We’re Looking For We’re looking for a highly experienced and hands-on technical expert with deep knowledge of medical devices and cold-chain equipment. You are confident operating in regulated environments, take ownership of complex challenges, and naturally lead and support others as a trusted SME. This role suits someone who combines strong technical depth with a proactive mindset, a passion for quality and compliance, and a drive to continuously improve service performance. Essential skills and experience: Proven hands-on experience in installation, fault finding, maintenance, calibration, and repair of medical, laboratory, or refrigeration equipment Strong technical expertise in laboratory, medical, and cold-chain systems, including a solid understanding of refrigeration principles and HVAC/building-related systems Demonstrable experience with HVAC systems, including operation, maintenance, and troubleshooting within technical or regulated environments Proven experience performing calibration activities aligned to ISO 17025, including IQ, OQ, and PQ validation processes Advanced diagnostic and troubleshooting capability, with the ability to resolve complex technical issues across multiple equipment types Experience working within regulated environments (e.g. GxP, GCP, GMP, ISO standards), with a strong understanding of compliance requirements High level of accuracy in documentation and record-keeping, ensuring all activities are fully traceable and audit-ready Proficiency in using calibration tools, diagnostic equipment, and interpreting technical documentation Strong electrical and/or electronic engineering knowledge, including the ability to read schematics and technical manuals Experience coordinating vendors, subcontractors, and external service providers, ensuring quality and compliance Proven ability to lead or support technical projects and contribute to continuous improvement initiatives Strong organisational and prioritisation skills, with the ability to manage multiple activities independently Excellent communication and stakeholder management skills Demonstrated ability to mentor and support other engineers, acting as a technical SME Strong awareness of Health, Safety & Environment (HSE) and COSHH requirements Experience using ERP systema and maintaining accurate engineering/service records Physically capable of working in a workshop environment, including lifting and moving equipment up to 25 kg Commitment to continuous professional development and maintaining up-to-date technical knowledge Desirable (but not essential): Formal qualifications or additional certification in advanced metrology or calibration disciplines beyond core ISO 17025 requirements Experience within clinical trials, pharmaceutical, biotech, or other life sciences environments Familiarity with audit processes and regulatory inspections, including supporting interactions with external auditors Experience working with calibration software, digital asset management systems, or paperless documentation tools Previous experience in a lead or senior engineering capacity, including supporting team coordination or workshop oversight Exposure to continuous improvement methodologies (e.g. Lean, Kaizen) and contributing to process optimisation initiatives Broad experience across a wide range of laboratory, medical, and cold-chain technologies Experience working in multi-site or global operational environments Strong commercial awareness, including supporting cost optimisation, equipment lifecycle planning, or service efficiency improvements What We Offer At Resonant, we’re more than a leading life sciences company, we’re a global team united by a shared purpose: the uncompromising pursuit of quality to help our customers move science forward. When you join us, you become part of a growing global community of more than 850 dedicated professionals. In return for your skills, knowledge, and experience, we are committed to helping you thrive, offering access to high-quality learning, development, and career progression opportunities so you can reach your full potential. This role is based on-site, with a requirement to work from the office for 5 days per week . Our competitive reward package includes, following qualifying periods: Healthcare coverage Pension scheme Flexible working options Associate engagement activities and wellbeing initiatives Generous annual leave, plus an extra day off to celebrate your birthday Join Us Whether you bring a background in life sciences or proven operational expertise, this is your opportunity to be part of a collaborative, high-performing team making a real difference. If you’re ready to take the next step in your career and help clients move their life science programmes forward with clarity and purpose—we’d love to hear from you. Apply now and join Resonant. At Resonant, we're more than a leading life sciences company. We're a global team dedicated to the uncompromising pursuit of quality to help our customers deliver on their mission: moving science forward. With touch points and products across clinical trial and diagnostic services - sourcing, supply chain and storage - we collaborate to solve our customers' most complex challenges. Want to join more than 850 dedicated Resonant team members (and growing) worldwide? Whether you bring the life sciences background or proven operations know-how, consider advancing your career with Resonant in one of our available roles. Join us in our mission: to help clients move their life science programs forward with clarity and purpose.
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