Position Details
Manufacturing Engineer Apply
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Insert Molding Process Leadership:
Lead the design, development, and optimization of insert molding processes specifically for medical devices. -
Manufacturing Operations Oversight:
Oversee daily manufacturing operations, ensuring production efficiency and adherence to quality standards. -
Process Optimization:
Analyze existing manufacturing processes to identify opportunities for cost reduction, cycle time improvement, and enhanced overall process efficiency. -
Technical Troubleshooting:
Provide technical support by troubleshooting process-related issues, resolving defects, and implementing corrective actions in a timely manner. -
Regulatory Compliance:
Work closely with the quality team to ensure compliance with industry standards, including FDA and ISO regulations, ensuring that all processes meet medical device manufacturing requirements. -
Project Management:
Independently manage projects from concept to production, develop project timelines, coordinate resources, and ensure timely project delivery. -
Cross-Department Collaboration:
Collaborate with Product Development, R&D, and other engineering teams to introduce and implement new manufacturing techniques and technologies. -
Documentation:
Maintain comprehensive documentation of all processes, including SOPs, validation protocols, and work instructions.
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Education:
- Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field.
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Experience:
- Minimum 5 years of experience in insert molding, with a strong preference for candidates experienced in the medical device industry.
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Technical Proficiency:
- Strong knowledge of process development, molding techniques, and troubleshooting insert molding processes.
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Regulatory Knowledge:
- Familiarity with medical device regulatory standards such as FDA and ISO 13485.
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Project Leadership:
- Ability to manage projects independently and lead process improvement initiatives from concept to execution.
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Analytical Skills:
- Strong analytical and problem-solving skills, with a focus on continuous improvement and cost-efficiency.
