Design Assurance Engineer III

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Date: May 27, 2023

Location: St. Paul – Minnesota, US, 55421

Company: Heraeus

Design Assurance Engineer III

Location Fridley

Permanent

Full Time

About Heraeus

Solutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and cutting-edge technologies to create products used all over the world with one thing in common: World-class quality.

About Heraeus Medevio

Together we improve lives. At Heraeus Medevio, we bring lifesaving and life-changing medical devices to market through partnerships with medical device manufacturing companies. Backed by Heraeus Group, a FORTUNE Global 500 listed company, we are committed to the growth of our teams and organization by providing an open space for open minds.

To reach our vision of improving 100 million lives every year, we foster a culture of curiosity that thrives on challenge, continuous learning, growth, and the opportunity to try new things. With sites in the United States, European Union, and Asia, and over 2,200 employees worldwide, together, we will meet tomorrow's challenges today.

What you'll get to do every day:

Actively participate in complex medical device design and development projects, collaborating across functional areas to support and drive project deliverables to completion
Design and/or specify inspection and testing plans/procedures/systems to ensure products conform to specifications and quality standards.
Propose and implement possible solutions/improvements, utilize the Corrective and Preventive Action (CAPA) system.
Investigate/analyze in-house nonconformances for finished devices and monitor quality trends.
Initiate, review, and approve disposition for Nonconforming Product
Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
Lead efforts to continuously improve product quality, while ensuring safety, efficacy and regulatory compliance.
Support all functional departments to ensure compliance with Quality System and lead continuous improvement efforts of the Quality System.
Represent Quality Assurance on product development teams, including developing Quality Plans and Risk Management Plans.
Facilitate customer audits and assist as needed with external audits such as FDA and ISO.
Interface with personnel from all areas of HMC to foster improved quality and reduced cost.
Provide input for quality management reviews
May mentor and provide guidance to Quality Assurance Technicians
May Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system
Ensure documentation accuracy and completeness of product and process development activities
Develop and monitor quarterly goals.
Provide periodic more formal updates on progress of projects.
Participate in company meetings and training sessions.
Other duties may be assigned as required.

What we're looking for in you:

Bachelor's Degree in Engineering (or related field required).
A minimum of 5 years related engineering work experience.
Experience is in the medical device industry as a Quality Assurance Engineer strongly preferred.
Experience with the use and application of gages, inspection tools, and test equipment.
Practical experience/familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, sterilization processes, cleanrooms, and other applicable standards.
Have a customer focused mindset and ability to work collaboratively across functional groups
Must be highly organized and can manage multiple projects concurrently.
Must possess practical knowledge related to products that the position will support (guidewires, catheters, leads, electromechanical devices, or related technologies).
Must possess good written and verbal communication skills as well as team building skills, basic PC skills, and have working knowledge of Microsoft Word, Excel, and Minitab.
Must be able to read and understand component/product specifications.

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Nearest Major Market: Minneapolis