Experience Inc. Jobs

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

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