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Sr. Manufacturing Engineer
Remote · China or US
Job Summary
Manufacturing Engineer III to optimize production processes, drive continuous improvement, and implement automation solutions in a regulated manufacturing environment. You will manage process validation, equipment qualification, and change control while collaborating with R&D, Quality, and Production to introduce new products, reduce costs, and enhance manufacturing capabilities. Strong analytical, communication, and cross-functional teamwork skills are required, with experience in regulatory compliance and lean manufacturing principles. The role includes supporting engineers and technicians, traveling up to 20%, and working in cleanroom environments when needed.
Required Qualifications
- Advanced Degree plus 3 years of experience in manufacturing engineering (preferred fields: Mechanical, Electrical, Chemical or related) in regulated industries (medical device or scientific instruments)
- Bachelor's Degree plus 5 years of experience in manufacturing engineering in regulated industries
- Experience with AI and automation systems development, PLCs, and manufacturing control systems
- Experience with CAD software and manufacturing documentation systems
- Expertise in process validation, equipment qualification, and change control management
- Proficient in statistical analysis and continuous improvement methodologies
- Lean Six Sigma certification preferred
- Strong knowledge of ISO standards and regulatory requirements
- Strong project management skills and ability to work with cross-functional teams
- Demonstrated success implementing process improvements and cost reduction initiatives
- Excellent analytical and problem-solving abilities
- Strong written and verbal communication skills
- Ability to travel up to 20% as needed
- Must be able to work in cleanroom environments when required
- Experience with risk assessment methodologies and root cause analysis
- Knowledge of lean manufacturing principles and tools
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