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Manufacturing Engineer Medical
2 months ago
We are seeking a highly skilled and experienced Manufacturing Engineer to join our team at Novarad Corporation. As a key member of our production team, you will be responsible for designing, developing, and implementing manufacturing processes to ensure the highest quality and efficiency in our medical device production operations.
Key Responsibilities- Process Development and Optimization
- Design and develop manufacturing processes to enhance efficiency, quality, and cost-effectiveness in production operations.
- Perform process optimization and automation to improve production efficiency and reduce costs.
- Production Management
- Manage daily production activities related to medical devices, ensuring on-time delivery and adherence to production schedules.
- Develop and implement production schedules, workflows, and procedures to meet output goals while maintaining high-quality standards.
- Regulatory Compliance
- Ensure compliance with FDA, ISO 13485, and Good Manufacturing Practices (GMP) regulations and standards.
- Develop and implement procedures to ensure adherence to regulatory requirements.
- Collaboration and Communication
- Collaborate with cross-functional teams, including R&D, Quality, and Operations, to ensure seamless production operations.
- Communicate effectively with production staff, management, and other stakeholders to ensure clear understanding of production goals and objectives.
- Education and Experience
- Bachelor's degree in Engineering, Manufacturing, Mechanical Engineering, Industrial Engineering, or a related field.
- At least 3 years of experience in a manufacturing engineering role, preferably in a regulated industry (medical devices, pharmaceuticals, etc.).
- Skills and Knowledge
- Strong knowledge of FDA regulations, ISO 13485, and GMP standards.
- Hands-on experience with process optimization, automation, and manufacturing technologies.
- Excellent problem-solving and analytical skills, with the ability to troubleshoot complex manufacturing issues.
- Strong organizational and communication skills.
- Work is performed primarily in a clean room with strict hygiene and contamination control protocols.
- Significant time is spent within office and administrative environments for meetings and reporting.
- The role involves exposure to production machinery, equipment, and occasional noise.
- Must wear appropriate personal protective equipment (PPE), including gowns, gloves, hairnets, and masks, when working in regulated areas.
- Ability to stand and walk for extended periods, frequently moving between production areas.
- Must be able to lift and carry up to 25 pounds.
- Frequent use of hands and arms to operate production equipment, tools, and controls.
- Good manual dexterity required for handling small parts and equipment components.
- Visual acuity to inspect products and read equipment monitors.
- Bending, reaching, and crouching as needed.