Quality Design Assurance Engineer I or Engineer II

Heraeus Group•Fridley, MN

33d•Onsite

About The Position

The Quality Design Assurance Engineer I or Engineer II will be an engaged core project team member supporting the design and development of complex medical device products. The Quality Design Assurance Engineer I or Engineer II represents the Quality Assurance function on multiple design and development projects, which can include catheters, guidewires, electrophysiology, and other related technologies. We are open to hiring at the Engineer I or Engineer II level. This position is an onsite position based in Fridley, MN with occasional need to travel to the White Bear Lake, MN location.

Requirements

Bachelor’s degree in Engineering or related field strongly preferred, other relevant postsecondary education, training and experience may be considered in lieu of a Bachelor’s degree.
Basic knowledge of engineering fundamentals.
Understanding of the medical device industry and quality assurance strongly preferred.
Experience with the use and application of gages, inspection tools, and test equipment strongly preferred
Practical experience/familiarity with some or all of the following: ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices, Good Laboratory Practices, ISO 14971, MDR, sterilization processes, cleanrooms, and other applicable standards.
Must be able to read and understand component/product specifications.
Ability to develop practical technical knowledge related to products that the position will support (guidewires, catheters, leads, electromechanical devices, or related technologies).
Possess a customer-focused mindset and ability to work collaboratively across functional groups.
Must be highly organized and can manage multiple projects concurrently.
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 willing and able to travel between Fridley, MN and White Bear Lake, MN sites, as needed.

Responsibilities

Participate in complex medical device design and development projects, collaborating across functional areas to support and drive project deliverables to completion
Support design and specifications for inspection and testing plans/procedures/systems to ensure products conform to specifications and quality standards.
Support the implementation of possible solutions/improvements, utilize the Corrective and Preventive Action (CAPA) system.
Review, and approve disposition for nonconforming product.
Review Change Orders, Deviation Authorizations, Verification/Validation Protocols, Final Qualification Protocol Reports, as well as Inspection Procedures.
Support efforts to continuously improve quality management systems and 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.
Provide input for quality management review.
Support customer audits and assist as needed with external audits such as FDA and ISO.
May Investigate/analyze customer complaints and support Regulatory Affairs to monitor customer complaint trends and maintain compliance to complaint system.
Maintain a positive demeanor while interacting with personnel from all areas of Medevio to foster improved quality and reduced cost.
Promote a quality culture by clearly communicating the importance of adherence to procedure, providing rationale and context behind decisions, and seeking out areas for continuous improvement.
Ensure documentation accuracy and completeness of product and process development activities.
Other duties assigned as required.