Job Title: Senior Manufacturing/Process Engineer – Catheter Manufacturing Location: Fridley, MN Employment type: Contract Position Overview: We are seeking a highly skilled and experienced Senior Manufacturing/Process Engineer with a strong background in catheter manufacturing. The ideal candidate will have 5-7 years of hands-on experience in the medical device industry, specifically with catheter production, and will be responsible for developing, optimizing, and scaling manufacturing processes to ensure product quality, efficiency, and cost-effectiveness. As a Senior Engineer, you will play a pivotal role in process improvements, troubleshooting, and ensuring compliance with regulatory requirements. Key Responsibilities: + Process Development & Optimization: Lead efforts to develop and improve catheter manufacturing processes, focusing on efficiency, cost reduction, and quality. + Troubleshooting & Problem-Solving: Provide technical expertise in identifying and resolving manufacturing issues, including process deviations, material defects, and equipment failures. + Cross-Functional Collaboration: Work closely with R&D, Quality, Supply Chain, and Operations teams to ensure smooth product transitions from prototype to mass production. + Process Validation: Conduct and oversee process validation activities, including IQ/OQ/PQ, ensuring processes meet all regulatory and quality standards. + Documentation & Reporting: Create and maintain detailed documentation for all processes, including SOPs, work instructions, and process flow diagrams. Ensure compliance with all internal and external regulatory requirements. + Continuous Improvement: Drive continuous improvement initiatives using Lean, Six Sigma, and other industry best practices to optimize manufacturing processes and reduce waste. + Training & Mentorship: Provide technical training and mentorship to junior engineers and manufacturing personnel, promoting best practices in catheter manufacturing. + Equipment Selection & Maintenance: Assist in the selection, installation, and commissioning of new manufacturing equipment and technology, and ensure proper maintenance and calibration. + Compliance: Ensure all processes comply with FDA, ISO, and other regulatory standards specific to catheter manufacturing. Qualifications & Requirements: + Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Industrial Engineering, or related field. + Experience: 5-15 years of experience in a manufacturing or process engineering role, with a strong focus on catheter or medical device manufacturing. + Technical Skills: + In-depth knowledge of catheter manufacturing techniques, such as extrusion, molding, and balloon catheter assembly. + Experience with process control, statistical process control (SPC), and design of experiments (DOE). + Familiarity with medical device regulations, including FDA QSR, ISO 13485, and other applicable standards. + Proficiency in CAD software (SolidWorks, AutoCAD) and process simulation tools. + Soft Skills: + Strong problem-solving abilities and analytical thinking. + Excellent communication and interpersonal skills to collaborate with cross-functional teams. + Ability to manage multiple projects simultaneously and meet deadlines. + Certifications: Six Sigma, Lean Manufacturing, or other relevant certifications are a plus. Preferred Qualifications: + Experience in catheter design or development in addition to manufacturing. + Knowledge of automation and robotics in medical device manufacturing. + Familiarity with cleanroom environments and sterile processing standards. Benefits: + Competitive salary and benefits package ($40-60/hr.) + Health, dental, and vision insurance + Paid time off Powered by JazzHR