Design Assurance Engineer I
About the role
Integer Holdings Corporation (NYSE: ITGR) is one of the largest medical device contract development and manufacturing organizations (CDMOs) in the world, serving the cardio and vascular, neuromodulation, and cardiac rhythm management markets. As a strategic partner of choice, we advance the goals of our medical device customers through industry-leading engineering and manufacturing, with a relentless commitment to quality, service, and innovation. The company's brands include Greatbatch Medical® and Lake Region Medical®. The primary purpose of this role is to support the Design Assurance group in areas including design verification, design validation, statistics, risk management, test method development and standards, sourced item qualification, test method validation, design input requirements (spec generation), ensuring design outputs meet inputs, design transfer support, process validation support for Integer owned products. DA supports process development projects. As an entry level associate, you will ensure that Integer’s internal and external customer expectations are met or exceeded with the direction, instruction and guidance from more experienced engineers and managers in your organization. You will learn the application of design assurance and product test development and testing concepts in the design & manufacture of Integer's product lines. You adhere to Integer’s Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
Responsibilities
- Assist in the development of new test methods and in the improvement of existing methods including design and manufacture of new tooling, fixtures, and templates.
- Assist in the testing and validation of new test methods including gage R&R studies