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

Overview

This Manufacturing Process Engineer-Medical Device designs, develops, and validates manufacturing processes for componets used in regulated medical devices and other life science applications. Ensures compliance with FDA, ISO regulations while optimizing production efficiency and supporting quality requirements.

Responsibilities

• Provides daily technical production support in the 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.
• Develop and maintain robust, cost-efficient manufacturing processes. Implement best practice methods and standard processes to maintain quality.
• Demonstrates ability to understand source(s) of variation and identify solutions for error proofing manufacturing processes.
• Uses statistical analysis tools, SPC, capability studies to ensure robust process control and in reducing variation in manufacturing process.
• Manage and document process validations, equipment installation, and manufacturing method improvements.
• Writes protocols and supporting IQ, OQ, PQ documentation.
• Support production with continuous improvement initiatives aimed at reducing waste and improving productivity performance.
• Conduct root cause analysis for product non-conformities, implementing corrective actions to prevent recurrence.

Qualifications

Qualifications:

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

Key Attributes

• The ideal candidate demonstrates being hands on in production and has a strong ‘bias for action’.
• Strong analytical and communication skills with a desire to work for a fast-paced organization
• Detailed understanding of process capabilitiy, Minitab
• Experience in a high-volume manufacturing organization
• Strong skills in collaborating with internal and external customers.

Additional Comments:

The essential functions have been provided as example of the type of work performed by employees assigned to this job classification. The company reserves the right to modify the work assignments and/or to make reasonable accommodations so that qualified employees can perform the essential functions. The job description is not intended to be an inclusive list of duties and responsibilities. It is intended to describe the general nature of the position.

Filtration Group now part of Parker Hannifin is an Equal Opportunity and Affidantive Action Employer. Parker is committed to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job related reasons regardless of race, ethnicity, color, religion, sex, sexual orientation, age, national origin, disability, gender identity, genetic information, veteran status, or any other status protected by law. However, U.S. Citizenship, Permanent Residency or other appropriate status is required for certain positions, in accord with U.S. import & export regulations.(“Minority / Female / Disability / Veteran / VEVRAA Federal Contractor”)

If you would like more information about Equal Employment Opportunity as an applicant under the law, please go to Employees & Job Applicants | U.S. Equal Employment Opportunity Commission

Drug-Free WorkplaceIn accordance with Parker’s policies and applicable state laws, Parker provides for a drug-free workplace. Therefore, all applicants seeking employment with Parker will be subject to drug testing as a condition of employment.