Engineer II, Manufacturing Engineering
Thermo Fisher Scientific
Manufacturing Engineer II at Thermo Fisher Scientific in Tijuana supports production processes and equipment optimization in a regulated manufacturing environment. The role involves managing technical projects, implementing process improvements, and collaborating across functions to ensure high-quality operations in medical device manufacturing.
Responsibilities
- Manage cross-functional technical projects involving process engineering, quality, operations, and regulatory teams
- Coordinate injection mold qualification and validation activities with supporting documentation
- Support manufacturing troubleshooting, mold transfers, new product introduction, and process improvements
- Develop project plans, track actions, manage timelines, and escalate risks through completion
- Train and support technical and manufacturing personnel on processes and procedures
Requirements
- Bachelor's degree in Manufacturing, Mechanical, Industrial Engineering, or related field
- 2+ years manufacturing engineering experience in regulated medical device environment
- Working knowledge of plastic injection molding processes, equipment, tooling, and materials
- Experience with injection mold qualification, validation protocols, IQ/OQ/PQ, and engineering documentation
- Proficiency in GMP, ISO 13485, FDA requirements, and quality system compliance
- Statistical analysis skills including process capability, MSA, and data trending; Minitab preferred
- Strong English communication and technical writing abilities for reports and presentations
Vacante publicada el 2 días atrás
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