Test Method Validation Engineer Job

Test Method Validation Engineer needed to perform the following duties:

Develop new test methods to support New Product Development (NPD) projects, ensuring they are aligned with product requirements and design specifications.
Validate test methods through Gage R&R (Repeatability and Reproducibility) studies, bias analysis, and linearity studies to ensure accuracy, precision, and consistency.
Ensure all test methods comply with regulatory requirements (e.g., FDA, ISO 13485) and are documented under Quality Management System (QMS) standards.
Perform statistical analyses to meet ISO requirements
Perform statistical analyses using tools like Minitab or JMP to validate test methods and ensure they meet ISO standards for reliability and reproducibility.
Conduct root cause investigations for issues related to test methods, components, or processes using methodologies such as 5 Whys, Fishbone Diagrams, and FMEA (Failure Mode and Effects Analysis).
Collaborate with suppliers to identify and resolve quality issues, ensuring timely implementation of corrective and preventive actions (CAPA).
Document investigation findings and present actionable recommendations to stakeholders to prevent the recurrence of issues.
Execute Keyence measurement routines to perform dimensional inspections and ensure components meet design specifications.
Conduct tensile testing and other mechanical tests to evaluate the performance and durability of materials and components.
Analyze test data to identify trends, anomalies, and opportunities for improvement, providing actionable insights to enhance product quality.
Support IQOQPQ activities and manage NPD projects
Manage NPD projects involving alterations to existing products, ensuring projects are completed on time, within scope, and in compliance with quality standards.
Handle molded components and transition to Windchill PLM for QMS processes
· Collaborate with suppliers to address any issues related to molded parts, such as dimensional inaccuracies or material defects.
· Ensure proper documentation and traceability of molded components throughout the production process.
· Work fully on-site to ensure effective project execution and collaboration with cross-functional teams.
· Participate in daily stand-ups, project meetings, and design reviews to provide technical input and ensure alignment with project goals.
· Foster a collaborative environment by actively engaging with team members and addressing any challenges that arise.

Bachelor’s degree is required in Mechanical Engineering or Engineering Management.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave