職務内容：

Coordinated phased approach of project implementation, minimizing disruption to production and distribution channels. Engineering change management for critical medical devices for the changes triggered by supplier change request, end of life, design transfer & compliance requirements. Led cross-functional teams including Regulatory Affairs, Labeling, Quality & Supply Chain, streamline change implementation and ensure compliance. Managed change control documentation, inventory coordination, and impact assessments for product labeling updates. Reported regularly to senior leadership, providing operational insights, risk mitigation strategies, and escalation support. Orchestrate project feasibility, prioritization and execution of the project adhering to the QMS policies and completing the project on schedule, ensuring compliance with CFR 820, ISO 13485, and IEC 60601. Develop and communicate the risk management plan and update other stakeholders through four box update and project update presentations. Communication with external stakeholder s component suppliers and PCB manufacturers and ensure alignment of their quality processes for any change implemented. Ensure the change order is incorporated with tasks that enable seamless transition of the change from part number extension across plants to costing and sales status updates. Formalized testing to execute those components. Execute qualification tests.Circuit design Medical devices Product Development , ISO13485 , ISO14791 , 60601 , FMEA , EMI/EMC , USB , Microprocessor , Microcontroller , Embedded Systems , Agile , Obsolescence Sustaining support Integration, Verification, Risk Management, Medical Devices, Medical Standards, Change Control

• Key Responsibilities
  1. To be responsible for providing technical guidance / solutions ;define, advocate, and implement best practices and coding standards for the team.
  2. To develop and guide the team members in enhancing their technical capabilities and increasing productivity
  3. To ensure process compliance in the assigned module| and participate in technical discussions/review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
  4. To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations.