Job Title: Industrial Engineer (Medical Device Industry)
Location: United States (Location details specific to the role)
Duration: 12 months (Contract on W2)

Job Description:

We are looking for a talented and detail-oriented Industrial Engineer to join our team within the medical device industry. In this role, you will focus on optimizing manufacturing processes, improving efficiency, and ensuring product quality in a regulated environment. You will collaborate closely with design, manufacturing, and quality teams to implement best practices, drive continuous improvement, and meet regulatory standards. This is an excellent opportunity to contribute to the development and production of medical devices that positively impact patient care.

• Analyze and improve production processes to increase efficiency, reduce waste, and optimize resource utilization in medical device manufacturing.
• Implement and maintain lean manufacturing principles and Six Sigma methodologies to improve productivity, reduce costs, and enhance product quality.
• Work closely with cross-functional teams to identify process improvements and streamline workflows, ensuring adherence to FDA, ISO 13485, and Good Manufacturing Practices (GMP) standards.
• Develop and maintain detailed process documentation, including work instructions, flow diagrams, and standard operating procedures (SOPs).
• Design and optimize plant layouts, equipment arrangements, and material handling systems to improve the flow of materials and reduce bottlenecks.
• Perform capacity planning and resource allocation to ensure manufacturing processes are scalable and efficient.
• Assist in the implementation of new technologies and manufacturing systems to support the production of medical devices.
• Conduct time studies, process simulations, and other analyses to identify opportunities for operational improvements.
• Support design transfer activities, ensuring that products are manufacturable and meet production requirements.
• Participate in risk management activities, including Failure Mode Effects Analysis (FMEA), to ensure the safety and quality of the product.
• Monitor and evaluate key performance indicators (KPIs) to track manufacturing performance and identify areas for improvement.
• Provide training and support to manufacturing teams to ensure they understand and adhere to process improvements and quality standards.

• Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or a related field.
• 2-5 years of experience in industrial engineering, preferably in the medical device or biomedical industries.
• Knowledge of FDA regulations, ISO 13485, and Good Manufacturing Practices (GMP) in the medical device industry.
• Experience with Lean Manufacturing, Six Sigma methodologies, and Continuous Improvement processes.
• Strong understanding of manufacturing processes and equipment, including materials handling, machining, assembly, and packaging.
• Proficiency in CAD software (e.g., AutoCAD, SolidWorks) and other tools for designing layouts and optimizing workflows.
• Experience with time studies, capacity planning, and process optimization techniques.
• Excellent problem-solving, analytical, and troubleshooting skills.
• Strong communication skills for documentation, training, and collaboration with cross-functional teams.
• Ability to work in a regulated and fast-paced environment while managing multiple projects effectively.

• Experience in the manufacturing of Class II or Class III medical devices.
• Six Sigma Green Belt or Black Belt certification.
• Familiarity with Statistical Process Control (SPC) and other data-driven methodologies for process monitoring and optimization.
• Experience with SAP, ERP systems, or similar tools for managing production data.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.