Quality Design Assurance Engineer I or Engineer II
Not Disclosed•Full-TimeOn-site
location_on4849, 5th Street Northeast, Columbia Heights, Anoka County, Minnesota, 55421, United States
About Heraeus
As a family-owned global technology group, Heraeus helps customers stay one step ahead in diverse fields, from making displays foldable to breathing new life into precious metals. We are committed to the growth of our teams and organization by providing an open space for open minds.
About Heraeus Medevio
Together, we improve lives. Heraeus Medevio brings lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by the Heraeus Group, we foster a culture of curiosity that thrives on challenge, continuous learning, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, we are dedicated to meeting tomorrow's challenges today.
About the Role
The Quality Design Assurance Engineer I or II will serve as an engaged core project team member, supporting the design and development of complex medical device products. This role represents the Quality Assurance function on multiple projects, including catheters, guidewires, electrophysiology, and related technologies. You will collaborate across functional areas to drive project deliverables to completion, ensuring products conform to specifications and quality standards while maintaining safety, efficacy, and regulatory compliance.
This is an onsite position based in Fridley, MN, with occasional travel required to the White Bear Lake, MN location.
Hiring Process
Curious? Apply now to join our team.
Equal Opportunity
Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We participate in E-Verify to confirm employment eligibility after hire.
Work location
Work model: On-site
4849, 5th Street Northeast, Columbia Heights, Anoka County, Minnesota, 55421, United States
Columbia Heights, Minnesota
Key Responsibilities
Similar Job Opportunities
Skills, education and keywords
Skills: Iso 13485, Fda Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, Iso 14971, MDR, Sterilization Processes, Cleanrooms, Microsoft Word.
Education: Bachelor's degree in Engineering or related field preferred.
Frequently asked questions about Quality Design Assurance Engineer I or Engineer II at Heraeus
What does a Quality Design Assurance Engineer I or Engineer II at Heraeus do?expand_more
In this Quality Design Assurance Engineer I or Engineer II at Heraeus role, you will participate in complex medical device design and development projects; support design and specifications for inspection and testing plans; utilize the corrective and preventive action (capa) system for improvements; and review and approve disposition for nonconforming product.
What are the requirements for this Quality Design Assurance Engineer I or Engineer II role?expand_more
Heraeus is looking for candidates who meet the following requirements: Bachelor's degree in Engineering or related field; Basic knowledge of engineering fundamentals; Understanding of medical device industry and quality assurance; Experience with gages, inspection tools, and test equipment; Familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, GMP, GLP, ISO 14971, MDR, sterilization processes, cleanrooms; and Ability to read and understand component/product specifications.