
Manufacturing Engineer
- Singapore
- Permanent
- Full-time
- Candidate able to Lead and mentor group of Engineers on their daily tasks and supervise on their daily routine.
- There will be a strong linkage with the Quality Assurance department in supporting the Regulatory and Compliance requirements of an ISO13485 organization.
- Candidate with Medical product understanding will be added advantage.
- 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.
- Strong communication skills
- 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.