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.
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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 Affirmative 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.
