Full-Time
Medical Device Subject Matter Expert
Technical Support & Service Engineer
Resonant Clinical
No salary listed
Chorley, UK
In Person
On-site work required five days per week.
Category
 IT & Security (1) |
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 Biology & Biotech (1) |
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Required Skills
HVAC
Metrology
GMP
Google Cloud Platform
Requirements
- Proven hands-on experience in installing, fault finding, maintaining, calibrating, and repairing medical, laboratory, or refrigeration equipment.
- Strong technical expertise in laboratory, medical, and cold-chain systems, including refrigeration principles and HVAC/building-related systems.
- Demonstrable experience operating, maintaining, and troubleshooting HVAC systems in technical or regulated environments.
- Proven experience performing calibration activities aligned with ISO 17025, including IQ, OQ, and PQ validation processes.
- Advanced diagnostic and troubleshooting capability across multiple equipment types.
- Experience working in regulated environments such as GxP, GCP, GMP, and ISO standards, with a strong understanding of compliance requirements.
- High accuracy in documentation and record-keeping, ensuring activities are traceable and audit-ready.
- Proficiency using calibration tools and 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 while ensuring quality and compliance.
- Proven ability to lead or support technical projects and contribute to continuous improvement initiatives.
- Strong organizational and prioritization skills, with the ability to manage multiple activities independently.
- Strong communication and stakeholder management skills.
- Demonstrated ability to mentor and support engineers as a technical subject matter expert.
- Strong awareness of Health, Safety and Environment and COSHH requirements.
- Experience using ERP systems and maintaining accurate engineering and service records.
- Physical capability to work in a workshop environment, including lifting and moving equipment up to 25 kg.
- Commitment to continuous professional development and maintaining current technical knowledge.
Responsibilities
- Act as the subject matter expert for medical, laboratory, and refrigeration equipment, including cold-chain systems and temperature-controlled devices.
- Deliver technical support, troubleshooting, and repair across equipment such as freezers, incubators, centrifuges, balances, and monitoring systems.
- Perform and oversee installation, commissioning, calibration, preventive maintenance, and corrective servicing.
- Lead ISO 17025-aligned calibration activities, including IQ, OQ, and PQ documentation and compliance.
- Support and coordinate daily workshop operations, including planning, prioritization, and workflow optimization.
- Lead team huddles and contribute to delivery against on-time-in-full and operational key performance indicators.
- Maintain accurate and compliant service records, calibration certificates, and enterprise resource planning 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 Environment and COSHH lead within the In-House Engineering function.
- Mentor and develop engineers by sharing knowledge and building technical capability across the team.
- Drive continuous improvement initiatives across processes, performance, and service delivery.
Desired Qualifications
- Formal qualifications or additional certification in advanced metrology or calibration disciplines beyond core ISO 17025 requirements.
- Experience within clinical trials, pharmaceutical, biotechnology, or other life sciences environments.
- Familiarity with audit processes and regulatory inspections, including supporting interactions with external auditors.
- Experience using 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 such as Lean and Kaizen and contributing to process optimization initiatives.
- Broad experience across laboratory, medical, and cold-chain technologies.
- Experience working in multi-site or global operational environments.
- Strong commercial awareness, including supporting cost optimization, equipment lifecycle planning, or service efficiency improvements.