Medical Device Manufacturing Process Engineer II

Filtration Group; Fairburn (GA); On-site; USD 110,000 - 140,000; Full time

Job summary

Filtration Group, now part of Parker Hannifin, seeks an experienced Manufacturing Process Engineer for medical-device manufacturing. The role focuses on designing, validating, and optimizing processes to meet regulatory and quality requirements while driving productivity.

The ideal candidate will have 7+ years in process engineering within manufacturing, hands-on production involvement, and strong abilities in validating equipment and processes for high-volume medical products.

Qualifications

• Bachelor’s degree in Mechanical, Industrial, or Chemical Engineering.
• 7+ years of process engineering / continuous improvement experience in a manufacturing setting.
• Proven track record of delivering productivity and cost improvements.
• Experience working directly with medical products and performing validations.

Responsibilities

• Provides daily technical production support in manufacturing processes and meeting daily targets for critical medical products.
• Works directly with customers and production in support of equipment & tooling validations along with supporting quality requirements.
• Develops and maintains robust, cost-efficient manufacturing processes. Implements best practice methods and standard processes to maintain quality.
• Demonstrates ability to understand sources of variation and identify solutions for error-proofing manufacturing processes.
• Uses statistical analysis tools, SPC, capability studies to ensure robust process control and reduce variation in manufacturing processes.
• Manages and documents process validations, equipment installation, and manufacturing method improvements.
• Writes protocols and supporting IQ, OQ, PQ documentation.
• Supports production with continuous improvement initiatives aimed at reducing waste and improving productivity performance.
• Conducts root cause analysis for product non-conformities, implementing corrective actions to prevent recurrence.

Skills

Process engineering

Continuous improvement

Manufacturing

Medical devices

Validation

SPC

Education

Bachelor's degree in Mechanical, Industrial, or Chemical Engineering

Tools

Minitab

Job description

Filtration Group, now part of Parker Hannifin, seeks an experienced Manufacturing Process Engineer for medical-device manufacturing. The role focuses on designing, validating, and optimizing processes to meet regulatory and quality requirements while driving productivity.

The ideal candidate will have 7+ years in process engineering within manufacturing, hands-on production involvement, and strong abilities in validating equipment and processes for high-volume medical products.