Validation Engineer

MGS has an exciting opportunity for a Validation Engineer to join our MGS Germantown Manufacturing team.

The Validation Engineer position is responsible for verifying all products meets the form, fit, and function requirements of MGS Customers and suitability for manufacturing.

Below are additional duties and responsibilities:

• Write and maintain technical documents such as Standard Documentation, Work Instructions, and Implementation plan for lab equipment and personnel as deemed necessary by the Quality Team.
• Implement lab equipment and quality software by creating a planning process that maintains integrity and requirements of the Quality Lab and personnel.
• Participate in print reviews to confirm the scope of a metrology event, confirm all necessary information is correct and available, and qualification requirements are met.
• Review and provide feedback on customer specifications.
• Sort, analyze, and interpret metrology data results as feedback to project team on process performance.
• Utilize data results to make decisions on next steps.
• Prepare Development and Qualification protocols and reports for project team and customer review.
• Define, plan, review, and approve Metrology System Analysis (MSA) requirements as it relates to the measurement of a specified part.
• Assist with Gage Repeatability and Reproducibility (GR&R) Studies.
• Assist with development of customized Metrology Systems according to MGS and Customer requirements and standards.
• Read, comprehend, and interpret engineering drawings and specifications.
• Review and interpret Geometric Dimensioning and Tolerancing (GD&T).
• Maintain a basic knowledge of manual inspection gages including, but not limited to, Calipers, Height Gages, Pin Gages, etc. for part verifications and measurements.
• Create and maintain part specific documentation during the Development process.
• Assist with troubleshooting Metrology System errors and variability.
• Develop, perform, and analyze First Article Inspections.

A qualified Validation Engineer candidate would fulfill these requirements:

• Completion of an accredited four-year university program in Mechanical Engineering, or in a related field of study
• 3-5 years of experience, or accrued on-the-job experience and training is required
• Working knowledge and application of Geometric Dimensioning and Tolerancing (GD&T)
• Experience with in the metrology scope, troubleshooting, software applications used in programming and data acquisition activities is recommended.
• Working knowledge with Solidworks, Creo, Calypso, PCDMIS, Minitab, MS Office and other quality related software is a plus.

About MGS

As a global provider of healthcare manufacturing solutions, MGS provides the right balance to drive vital innovations: robust end-to-end solutions combined with the strong customer focus and seamless collaboration of an agile partner. That’s why we’re the engineering and manufacturing partner of choice for today’s leading Pharma, Diagnostic and Med Tech innovators. Serving customers from around the world, we transform our customers’ most pressing challenges into innovations that improve lives.

To learn more about MGS, please visit  .

MGS Mfg. Group is committed to providing equal employment opportunity to all applicants and employees regardless of their race, creed, color, religion, gender, age, national origin, disability, military service, protected veteran status, genetic information, sexual orientation, gender identity, transgender status, or any other characteristic protected by federal, state or local law. We are strongly committed to this policy and believe in the concept and spirit of the law.

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