Advanced Manufacturing Engineer-MES
21 Minutes ago • 8 Years +
Manufacturing
Job Description
This role is for an Advanced Manufacturing Engineer-MES at Philips in Suzhou, focusing on quality control, line sustaining, lean manufacturing, equipment troubleshooting, and digital transformation. The ideal candidate will have a B.S. or higher in electrical/electronic engineering, 8+ years of experience in medical device manufacturing, and expertise in quality systems, lean methodologies, and data analysis to drive continuous improvement and ensure product quality.
Good To Have:
- Experience of X-Ray testing.
Must Have:
- Conduct root cause analysis and implement solutions.
- Evaluate design and supplier changes for quality impact.
- Lead analysis of customer complaints (DEFOA, MOA, WOA, DOA).
- Support QMS requirements and audits (TUV, CFDA, FDA).
- Update and train on Work Instructions (WI) and Device History Records (DHR).
- Perform daily Non-Conformance (NC) analysis and drive improvements.
- Support production equipment installation, maintenance, and repair.
- Execute Engineering Change Orders (ECO) in production.
- Introduce new products, processes, and parts.
- Improve production efficiency using lean methods and automation.
- Optimize processes and eliminate waste.
- Lead lean activities and improvement projects.
- Familiarity with electrical test platforms.
- Define User Requirement Specifications (URS) for new equipment.
- Define gauge calibration requirements.
- B.S. or above in electrical or electronic engineering.
- 8 years of experience in medical device manufacturing or assembly/testing.
- Familiarity with FDA Quality Systems Regulations and ISO13485.
- Experience with Windchill and SAP.
- Knowledge of Six Sigma and Lean manufacturing.
- Knowledge of process verification and validation.
- Knowledge of EMC and regulatory test requirements.
Manufacturing Engineer
Your Role:
- Quality Control and Improvement
- Ability to conduct root cause analysis; work out short/long term solution with functional team to mitigate line interruption.
- Evaluate design change and supplier change request to identify potential impact to product quality.
- Support MQ and SQE to conduct incoming failure parts analysis.
- Take lead to analyze customer complaint and DEFOA, MOA, WOA, DOA.
- Work with quality team to fulfil QMS requirement and support TUV, CFDA, and FDA audit.
- Line Sustaining
- Update WI and DHR according to ECR from designer or PPC.
- Execute WI training and technical training to manufacturing team.
- Daily NC analysis, find root cause and drive improvement.
- Support equipment team to install, verify, maintain and repair production equipment.
- Support change controller to execute ECO in production on time and minimize the line interruption.
- Introduce new product / new process / new part in production.
- LEAN and Cost Reduction
- Continuously improve production efficiency by standardized work, line balance and automation project.
- Optimize production process and eliminate waste using lean method and tools.
- Organize and lead the lean activities and other improvement project.
- Equipment Trouble Shooting and Improvement
- Familiar with electrical test platform.
- Identify opportunities to improve current equipment or create new equipment and work with R&D or supplier to realize the requirement.
- Define the URS to guide new equipment purchasing and the equipment qualification.
- Define the gauge calibration requirement.
- Digital Transformation and data analysis
You're the right fit if:
- B.S. or above in electrical, electronic engineering.
- Familiar with AC, DC design and tuning.
- Experience of X-Ray testing is preferred.
- 8 years of experience working in medical device manufacturing or finish medical device assembly or testing.
- Familiar with FDA Quality Systems Regulations and ISO13485 Quality System.
- Experience of Windchill and SAP.
- Knowledge and methodology of six sigma and Lean manufacturing.
- Knowledge of process verification and validation knowledge.
- Knowledge of EMC and regulatory test requirement.
How we work together
We believe that we are better together than apart.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
- Learn more about our business.
- Discover our rich and exciting history.
- Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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