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 .
Qualifications : Education :
Education :
Bachelor's degree in Mechanical Engineering , Industrial Engineering , or a related field.
Experience :
Minimum 5 years of experience in insert molding , with a strong preference for candidates experienced in the medical device industry .
Technical Proficiency :
Strong knowledge of process development , molding techniques , and troubleshooting insert molding processes.
Regulatory Knowledge :
Familiarity with medical device regulatory standards such as FDA and ISO 13485 .
Project Leadership :
Ability to manage projects independently and lead process improvement initiatives from concept to execution.
Analytical Skills :
- Strong analytical and problem-solving skills, with a focus on continuous improvement and cost-efficiency .
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