POSITION SUMMARY:

This position is responsible for identifying waste and bottlenecks in the manufacturing processes and then using engineering principles to make improvements to the systems to minimize those wastes. Responsible for keeping the production costs down while maintaining the quality and customer availability of the final product without compromising employee safety or regulatory compliance.

EDUCATION/EXPERIENCE:

• BS degree in Industrial Engineering, Manufacturing Engineering, or Mechanical Engineering
• 3+ years of experience in manufacturing or industrial engineering preferred
• Experience in biomedical manufacturing and knowledge of Six Sigma Tools, GMP and ISO requirements related to manufacturing preferred

SKILLS/COMPETENCIES:

• Experience evaluating and troubleshooting manufacturing processes and machinery
• Experience using CAD, CAM, data analysis programs, and related software
• Excellent verbal and communication skills
• Strong organization and project management skills
• Proficiency in Microsoft Office
• Experience with the design and monitoring of key manufacturing performance indicators
• Strong analytical thinker with ability to creatively solve problems
• Ability to hit deadlines with quality results
• Teamwork skills
• Good information technology skills
• Commercial awareness

• Monitor production yield and ensure that the yield is maintained above the standards for all products
• Work closely and collaborate with production, quality engineering, process engineering and product development to ensure seamless production and product development
• Establish and maintain quality standards throughout the manufacturing process, ensuring products meet specifications and customer expectations
• Ensure manufacturing processes and equipment comply with relevant industry standards, safety regulations, and environmental guidelines
• Investigate and resolve issues related to production, equipment malfunctions, and process inefficiencies
• Evaluate and improve existing manufacturing processes, identify bottlenecks, and implement solutions for waste reduction, increase efficiency and reduce costs
• Design new manufacturing systems, including equipment, tooling, and layouts, to optimize production flow and efficiency
• Manage projects related to process and quality improvements, equipment installations, efficiency improvement and cost reductions
• Interface with product development to ensure manufacturability of new products
• Develop and execute protocols for equipment qualifications and process validation in accordance with GMP and FDA compliance
• Create and Update SOPs and WIs that are compliant and easy to understand and train manufacturing personnel on proceduresConduct PFMEAs (Process Failure Mode Effects Analysis) as needed
• Develop detailed layouts for equipment, processes, and workflow to optimize operational efficiency
• Analyze production processes, schedules, methods and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process
• Review and calculate labor, material and other production costs
• Adhere to the policies and practices from the Quality Management System based on regulatory requirements for medical device manufacturing under FDA Quality System Regulation and/or ISO 13485 and contribute towards maintaining a safe work environment
• Any other duties that may be required or assigned