What are the responsibilities and job description for the Manufacturing Engineer position at TekOne IT Services Pvt. Ltd.?
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:
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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