Medical Device SME (Subject Matter Expert) Technical Support & Service Engineer
Role details
Job location
Tech stack
Job description
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., * 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
Requirements
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, * 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, 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.
Benefits & conditions
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