M
Senior Validation Engineer
Accepting applicationsMedix™ · Maple Grove, MN
Contract Mid_senior
Posted
2d ago
Category
Verification
Experience
Mid_senior
Country
United States
About the Role
We are seeking an experienced Senior Validation Engineer. Driven by a robust pipeline of upcoming Design Verification (DV) work, you will take ownership of a high volume of validation activities, with a heavy emphasis on Test Method Validations (TMV) and Gauge R&Rs. If you are a data-driven engineer who thrives in a fast-paced medical device manufacturing environment and has a strong grasp of statistical analysis, we want to hear from you. We can also offer relocation assistance.
Responsibilities
Take charge of upcoming validation projects, focusing heavily on executing Test Method Validations (TMV) and Gauge R&R studies.
Write robust protocols, coordinate execution, and document reports for IQ/OQ/PQ (Installation, Operational, and Production Qualification) runs for upcoming validation builds.
Provide dedicated engineering support to an active product line currently moving through the Design Verification (DV) phase.
Evaluate the quality, accuracy, and capability of measurement systems to ensure strict consistency and reproducibility.
Required Skills
Proven track record of creating, developing, and executing Test Method Validations (TMV) from scratch.
Extensive experience conducting Gauge R&Rs, measurement system analysis (MSA), and evaluating equipment consistency.
Strong understanding of statistical methods, particularly applying process capability metrics to validation data.
Show more Show less
We are seeking an experienced Senior Validation Engineer. Driven by a robust pipeline of upcoming Design Verification (DV) work, you will take ownership of a high volume of validation activities, with a heavy emphasis on Test Method Validations (TMV) and Gauge R&Rs. If you are a data-driven engineer who thrives in a fast-paced medical device manufacturing environment and has a strong grasp of statistical analysis, we want to hear from you. We can also offer relocation assistance.
Responsibilities
Take charge of upcoming validation projects, focusing heavily on executing Test Method Validations (TMV) and Gauge R&R studies.
Write robust protocols, coordinate execution, and document reports for IQ/OQ/PQ (Installation, Operational, and Production Qualification) runs for upcoming validation builds.
Provide dedicated engineering support to an active product line currently moving through the Design Verification (DV) phase.
Evaluate the quality, accuracy, and capability of measurement systems to ensure strict consistency and reproducibility.
Required Skills
Proven track record of creating, developing, and executing Test Method Validations (TMV) from scratch.
Extensive experience conducting Gauge R&Rs, measurement system analysis (MSA), and evaluating equipment consistency.
Strong understanding of statistical methods, particularly applying process capability metrics to validation data.
Show more Show less