What are the responsibilities and job description for the Sr. Manufacturing / Process Engineer - Catheter position at LCI-Lawinger Consulting?
Job Description
Job Description
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 :
In-depth knowledge of catheter manufacturing techniques, such as extrusion, molding, and balloon catheter assembly.
Strong problem-solving abilities and analytical thinking.
Preferred Qualifications :
Benefits :
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Salary : $40 - $60
