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Responsibilities
Production & Process Optimisation
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Develop and refine manufacturing processes for custom medical battery packs and power solutions.
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Identify efficiency improvements through Lean, Six Sigma, and Kaizen methodologies.
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Support the design transfer process from R&D to full-scale manufacturing.
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Ensure adherence to ISO 13485, ISO9001, ISO13485 and FDA standards for medical battery production.
Quality & Compliance
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Implement and maintain Good Manufacturing Practices (GMP).
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Conduct root cause analysis (RCA) and corrective actions for process deviations.
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Work closely with Quality and Regulatory teams to ensure compliance with medical device regulations.
Equipment & Automation
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Oversee the maintenance, calibration, and performance optimisation of assembly, welding, and testing equipment.
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Design and coordinate the manufacture of fixtures required to produce existing and new battery designs.
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Assist in integrating automation solutions to enhance production throughput.
Collaboration & Leadership
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Train and support production teams on new processes, safety protocols, and quality standards.
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Assist in the manufacture of prototype batteries.
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Assist other members of the Engineering staff with design reviews in order that ‘design for manufacture’ principles are followed.
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Work with procurement and supply chain teams to ensure availability of critical battery components.
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Provide technical expertise for new product introduction (NPI) and process validation.
Preferred Qualifications/ experience
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Experience in lithium-ion battery assembly, cell testing, and smart battery pack design.
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Understanding of electrochemical safety, thermal management, and regulatory standards for medical batteries.
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Certification in Six Sigma (Green/Black Belt) or Lean Manufacturing.
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Experience with Work Instructions, Process Flowcharts, PFMEA, and Control Plans.
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Manual and/or Computer Aided Machining Experience (e.g. Milling, 3D Printing)
Education and Training:
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Engineering HNC in mechanical engineering as a minimum.
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A degree in mechanical, manufacturing, or design-based engineering (or equivalent) preferred.
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3- 5 years industry experience is preferred, but not essential