Process Leadership & Regulation: Lead the evaluation, design, and optimization of manufacturing processes by applying advanced knowledge of PCBA fabrication, mechanical assembly, tooling, and materials in compliance with ISO 13485 and medical regulatory standards.
Validation & Verification: Own and execute process validation protocols including IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for new or modified equipment and manufacturing lines.
Efficiency & Scale-Up: Drive manufacturing efficiency and product scale-up initiatives by analyzing workflow, spatial requirements, and equipment layouts using Lean Manufacturing principles.
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Sales Support: Provide technical assistance to the Sales team by addressing inquiries, preparing relevant documentation, and offering solutions to product-related questions.
Engineering Calculations and Documentation: Perform basic engineering calculations and support the creation of detailed process documentation for new product introductions.
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Monitor daily production activities to ensure output meets quality standards, production targets, and customer delivery schedules.
Diagnose and resolve production issues including machine breakdowns and process inefficiencies and coordinate corrective actions with maintenance teams.
Support equipment maintenance activities to minimize downtime and improve production reliability.
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Support Plant Manager in daily operational related matters. Supervise and train plant personnel along with Plant Manager to ensure safe, reliable and optimum unit operations.
Assist plant manager in MOC preparation and execution, safe working permit preparation, plan TAR activities and execution, root cause analysis & troubleshooting, Risk Analysis, SWP, FMEA and HIRARC review
Inspect and assess unit conditions, highlight abnormalities and issues and take immediate actions for safe and effective resolutions.
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Support Plant Manager in daily operational related matters. Supervise and train plant personnel along with Plant Manager to ensure safe, reliable and optimum unit operations.
Assist plant manager in MOC preparation and execution, safe working permit preparation, plan TAR activities and execution, root cause analysis & troubleshooting, Risk Analysis, SWP, FMEA and HIRARC review
Inspect and assess unit conditions, highlight abnormalities and issues and take immediate actions for safe and effective resolutions.
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Responsible for the process design, operation and implementation
Responsible for the smooth running of the ongoing process
Prepare and maintain all engineering documents (manuals, modification, work instruction, etc) relating to the manufacturing of product and ensuring that change notices are raised and approve accordingly
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