Electrical Safety Lab Manager / Medical Devices

Applus+ 3C Test (part of Applus+ Laboratories) is a worldwide leader in the testing, inspection and certification sector. We primarily provide EMC (electromagnetic compatibility) testing in the Automotive sector, but we also test in the Military and Commercial sectors as well to EMC, Vibration and Environment testing requirements.

We are seeking an experienced and highly motivated Electrical Safety Lab Manager to lead our medical device testing laboratory, specializing in compliance evaluations against IEC 60601 / IEC 61010 series standards. The successful candidate will manage day-to-day lab operations, ensure compliance with international standards and accreditation requirements, lead a team of engineers/technicians, and interact with clients and regulatory bodies to ensure high-quality service delivery.

Leadership & Team Management:

• Lead and manage a team of test engineers and technicians.
• Assign and prioritize testing activities to ensure efficient workflow.
• Provide technical mentoring, performance reviews, and staff development.

Technical Oversight:

• Serve as the subject matter expert for IEC 60601 series, including related collateral and particular aspects.
• Ensure proper implementation and interpretation of testing requirements.
• Review and approve test plans, test data, and technical reports.

Quality & Compliance:

• Ensure compliance with ISO/IEC 17025 accreditation requirements.
• Support internal and external audits, including regulatory and accreditation body assessments.
• Maintain full compliance with ISO/IEC 17025 and MHRA-recognised quality systems.
• Liaise with Internal Quality Manager, UKAS and other relevant bodies during audits and assessments.
• Ensure traceability, repeatability, and reproducibility across all laboratory activities.

Project & Client Management:

• Interface with clients to clarify technical requirements, provide updates, and resolve issues.
• Oversee project timelines, resources, and deliverables to meet client and regulatory expectations.
• Provide technical support during product development and pre-compliance testing stages.

Lab Operations & Asset Management

• Oversee all operational aspects of the laboratory, including scheduling, test equipment calibration, and maintenance.
• Ensure lab safety protocols are met in accordance with UK health and safety regulations.
• Contribute to strategic planning for capital investment in new testing capabilities.
• Maintain and calibrate laboratory equipment and test setups.
• Ensure the lab meets safety regulations and that staff are trained on safety procedures.
• Plan for equipment upgrades and new test capabilities.

Essential:

• Degree-qualified in Electrical, Electronics or Biomedical Engineering (BEng, BSc, MEng, or equivalent), or related field.
• A minimum of 3 years’ experience in laboratory management in electrical safety field and most desirable in medical device testing environment.
• At least 2 years in a managerial or senior supervisory capacity.
• Proven expertise in IEC 60601 testing and evaluation, including familiarity with associated standards and IEC 62366. A proven experience in the field of electrical safety testing in the field of Household and is desirable
• Demonstrable understanding of ISO 17025 laboratory management systems.
• Prior experience interacting with UKAS, MHRA, or Notified Bodies.
• Working knowledge of UKCA marking and EU MDR requirements.
• Familiarity with electrical safety standards such as IEC 60335 / IEC 62368 / IEC 61010 or IEC 62368 is advantageous

Technical Skills:

• In-depth knowledge of main electrical safety standards and concepts, especially IEC 60601-1 and applicable collateral/particular standards.
• Strong understanding of risk management (ISO 14971) and usability engineering (IEC 62366) as they relate to IEC 60601.
• Experience with test equipment, electrical safety analysers, EMC chambers, and environmental test systems are advantageous.

Other Skills:

• Excellent communication and interpersonal skills.
• Strong organizational, project management, and leadership capabilities.
• Proficiency in technical report writing and customer communication.

Qualifications:

• Experience with ISO 17025 lab accreditation and quality systems.
• Knowledge of regulatory frameworks (FDA, MDR, etc.) for medical devices.

• Competitive salary and performance-based incentives.
• Opportunities for professional development and technical training.
• A dynamic, purpose-driven working environment within a respected testing and certification organisation.
• Starting date: Immediate.