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. Experience and Skills 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 within 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 MedTech 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. The information you provide below is optional and your resume will be given the same consideration regardless of your answer to the following questions. Male Female I Decline To Answer Hispanic or Latino (Persons of Mexican, Puerto Rican, Cuban, South or Central America, or other Spanish culture or origin, regardless of race) White or Caucasian (Not Hispanic or Latino) - Persons having origins in any of the original peoples of Europe, the Middle East or North Africa. Black or African American (Not Hispanic or Latino) - Persons having origins in any of the black racial groups of Africa. (Not Hispanic or Latino) - Persons having origins in any of the original people of North and South America and maintain cultural identification through tribal affiliation or community recognition. Asian (Not Hispanic or Latino) - Persons having origins in the Far East, Southeast Asia or the Indian subcontinent including Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand and Vietnam. Native Hawaiian or Other Pacific Islander (Not Hispanic or Latino) - Persons having origins in Hawaii, Guam, Samoa or other Pacific Islands. Two or More Races (Not Hispanic or Latino) - All persons who identify with more than one of the above five race categories. I Decline Veteran This employer may be a Government contractor subject to the Vietnam Era Veterans' Readjustment Assistance Act of 1974, as amended by the Jobs for Veterans Act of 2002, 38 U.S.C. 4212 (VEVRAA), which requires Government contractors to take affirmative action to employ and advance in employment: Disabled veterans; Recently separated veterans; Active duty wartime or campaign badge veterans; Armed Forces service medal veterans. #J-18808-Ljbffr