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Electrical Safety Lab Manager / Medical Devices
Salary not available. View on company website.
Applus+, Towcester, Northamptonshire
- Onsite working
- Full time
- Permanent
Posted today, 29 May
Job ref: 3434224179e14bf9a6b1b420e196116b
Full Job Description
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
+ 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.
+ Preferred 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 concept and especially in 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.
Preferred 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.
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