Yeoh Chun Wei
Senior Manufacturing Engineer
Summary
Diversified 14 years of manufacturing experience as a dedicated and resourceful Senior Manufacturing Engineer in fast-paced medical device and semiconductor manufacturing environment with excellent communication, problem-solving, data-driven analysis mindset, critical thinking skills and bring wealth of manufacturing knowledge ranging from process development, process improvement and proven successful production transfer record who strongly promote team work spirit.
Overview
14
14
years of professional experience
2
2
Certifications
1
1
Language
Work History
Senior Manufacturing Engineer
Biotronik APM Pte Ltd
05.2019 - Current
- Overmolding, glue dispensing & tube mounting process)
- Industry : Medical Device Manufacturing & operation
- General Responsibilities
- Lead junior production engineer in engineering team
- Lead and drive project plan using project management tool such as project plan, critical path analysis and work breakdown structure (WBS) to coordinate with logistic, quality, equipment and project team members to manage and achieve deliverables in term of objective, timeline, resources and budget to meet stakeholder’s expectation
- Lead and plan IQ, OQ & PQ validation activities timeline including material, production and equipment resources preparation for validation activities
- Develop,maintain and execute IQ, OQ & PQ including documentation (protocol & report)
- Lead & initiate continuous improvement project to improve manufacturing process and equipment for better productivity/output, defect reduction, capacity expansion & operation cost reduction by using Six sigma and lean methodology
- Develop manufacturing process training and documentation (work instructions) for production to ensure smooth transition of newly implemented process and procedure
- Provide engineering support to production to meet daily output target by resolving technical quality issues & equipment troubleshooting
- Drives and troubleshoots out-of-control situations, process issues and put containment and corrective actions in place
- Collaborate with Berlin’s counterpart for cross site quality issue and improvement plan
- Participate as a Process Subject Matter Expert (SME) auditee in internal & external ISO13485 audit
- Provide training and coaching to peer/cross-function engineer, equipment technician & operator on new equipment, process in-depth knowledge and procedures
- Improves manufacturing efficiency through workflow, space and equipment layout optimization
- Drive complex manufacturing process and quality issue by proposing test plan, execution and resources planning
- Lead and drive CAPA/Non-conformance with cross function team (R & D, production, quality and equipment) for complex quality issue by applying systematic DMAIC approach such as fishbone diagram, 5 whys analysis, hypothesis test etc
- Monitor key performance indicators, analyze them periodically, monitored deviations in the process and initiate corrective actions
- Relate, plan, validate, co-ordinate with vendors for integration semi/automated of manual processes
- Implement concepts of Poka Yoke, SMED into assembly tooling and fixtures.
Manufacturing Engineer
Resmed Asia Pte Ltd
09.2017 - 05.2019
- Assembly automation)
- Industry : Medical Device Manufacturing & operation
- General Responsibilities
- Lead in preparing IQ, OQ & PQ validation activities timeline for legacy & NPI product to meet target date for product launch
- Arrange production resources and material for validation activities
- Manage drafting, updating & completing of IQ, OQ & PQ process validation plan & documentation (protocol & report)
- Develop and maintain Bill of Material (BOM) and routing setup for NPI product after product transfer to production
- Participate in providing product, assembly process & packaging DFM (Design for manufacturing) inputs to R & D team in support of NPI during product design phase
- Manage drafting, & revising of assembly procedure & developing PFMEA to maintain Good Manufacturing Practice (GMP) & provide improvement action to mitigate process related risk
- Supports production by resolving technical issues & equipment troubleshooting as required
- Conduct process study using DOE (Design of Experiment) to achieve process optimization
- Engage with Quality Assurance (QA) team in internal & external audits – Medical Device Single Audit Program
- (MDSAP)
- Provide training to technician & operator on new equipment, processes & procedures
- Lead & initiate continuous improvement project for better productivity/output, quality, capacity expansion & operation cost reduction
- Lead automation project in manufacturing team for mask assembly, packaging process & productivity improvement
- Engage with QA team in providing technical support for non-conformance (NC) incoming & production assembled parts
- Engage external automation supplier for new jig, fixture fabrication & repair & new semi-auto/automated machine development for assembly process improvement.
Process Development Engineer
Becton Dickinson Medical Pte Ltd
06.2014 - 08.2017
Process Engineer
AMS-OSRAM Asia Pacific Pte. Ltd
05.2011 - 05.2014
- Glue dispensing/Replication/Vacuum Injection Molding)
- Industry: Semiconductor - Wafer Fabrication Frontend Manufacturing (Sensor, Camera,
- LED & flash module)
Process Engineer
Sunedition (M) Sdn Bhd
02.2010 - 05.2011
- Industry: Semiconductor- Wafer Fabrication Frontend Manufacturing
Process Engineer
Carsem (M) Sdn Bhd
05.2008 - 02.2010
- Die Attach/Die Bond)
- Industry: Semiconductor- Backend Manufacturing IC Packaging
Education
Bachelor Degree of Mechanical Engineering - Industrial Engineering
University Technology Malaysia (UTM)
Skills
Minitab
undefinedCertification
Six Sigma Green Belt (DMAIC & PDCA)
Accomplishments
- Resolved product issue through consumer testing.
· Lead production transfer from Germany to Singapore & completed process validation successfully
· Successfully setup new production line in Singapore manufacturing plant
· Lead production capacity expansion project successfully by increasing 30% production capacity using line balancing approach
· Lead and resolve complex quality issue by reducing 5% reject through CAPA process
· Developed & validated new automated machine for sleep apnea mask tubing assembly which improved productivity & reduced operator headcount by 50%
· Improved & reduced overmolding deburring time by 50% through mold optimization
Timeline
Senior Manufacturing Engineer
Biotronik APM Pte Ltd
05.2019 - Current
Manufacturing Engineer
Resmed Asia Pte Ltd
09.2017 - 05.2019
Process Development Engineer
Becton Dickinson Medical Pte Ltd
06.2014 - 08.2017
Process Engineer
AMS-OSRAM Asia Pacific Pte. Ltd
05.2011 - 05.2014
Process Engineer
Sunedition (M) Sdn Bhd
02.2010 - 05.2011
Process Engineer
Carsem (M) Sdn Bhd
05.2008 - 02.2010
Bachelor Degree of Mechanical Engineering - Industrial Engineering
University Technology Malaysia (UTM)
Six Sigma Green Belt (DMAIC & PDCA)
Project Management Professional (Microsoft Project)
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