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Design Assurance Engineer III at Integer - ApplyBlast

Design Assurance Engineer III

Integer

4 months ago

3.2 on Glassdoor

Plymouth, MN

Onsite

Full Time

Senior

0 applicants

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About this role

The Design Assurance Engineer III at Integer ensures device design and development adherence to Quality Management Systems, FDA regulations, and safety standards. This role leads risk management activities, performs design verification and validation, and manages supplier qualification for medical devices. Engineers in this position collaborate across R&D and manufacturing teams to develop test methodologies and maintain risk documentation for regulatory submissions.

Responsibilities

Lead risk management activities per ISO 14971 for Class 2 or 3 devices
Perform design verification and validation protocols and reports
Coordinate supplier qualification and support risk management initiatives
Investigate non-conforming material and prepare corrective action reports
Maintain risk management files for the lifecycle of medical devices

Skills

Qualifications

Bachelor's degree in Mechanical Engineering5 years of experience in quality engineeringMaster's degree in Mechanical Engineering (alternative)

About Integer

integer.net

Headquarters

Plano, Texas, United States

Company Size

10001+ employees

Founded

1940

View Profile

nteger 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®.