Manufacturing Engineer
4 weeks ago
JOB SUMMARY
Manufacturing Engineer will be responsible for planning, designing, implementing, and managing integrated, production and service delivery systems that assure performance, reliability, maintainability, schedule adherence and cost control within the production site. The Manufacturing Engineer will adopt as its goals profitability, effectiveness, adaptability, responsiveness, quality, and the continuous improvement of products and services throughout their life cycles.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organization.
- Manages IQ, OQ & PQ Validation activities.
- Generate validation and test protocols, monitor testing, issue qualification test reports, and approve components for use in products.
- Able to perform medical assembly process for High Level Assembly (HLA). Create procedures for processes and train staffs accordingly.
- Knowledge on assembly drawing, interpretation part drawing and specification is a must.
- Report writing, perform DFM and able to communicate within internal and external stakeholders.
- Strong understanding on PFMEA, Process Flow, Control Plan and Process risk Assessments.
- Communicate frequently with operations, technical, and quality representatives within area of support through the tier process.
- Provide leadership and commitment in supporting continuous improvements in quality, productivity, and delivery performance through the deployment of continuous improvement framework.
- Reviews all input from Engineering Department, ECO's, new product releases, configuration control policies, marking requirements, and participates in the DFM process.
- Solid understanding on BOM, ECN process, PCN and shop floor management will good plus.
- Monitor and continuously improve daily quality/efficiency performance for assigned areas. Exposure on Lean Tools example Cycle Time, TAKT Time, LBR is key, waste reduction etc would point to gauge.
- Proven record of accomplishment of successful change management accomplishments, implementing and management continuous improvements and cost reduction programs
- Involve on new product development by working with R&D, New Product Development and Quality to provide Design for Manufacturability guidance on hardware.
- Adhere to all safety and health rules and regulations associated with this position and as directed by supervisor. Comply with all procedures within the company security policy.
REQUIREMENTS:
- Candidate must possess at least a Degree, Engineering (Mechatronic/Mechanical) or equivalent. At least 5 year(s) of working experience in the related field is required for this position.
- Strong communication skills
- Candidate with Medical product understanding will be added advantage.
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