Senior Engineer - Quality Design Assurance

Heraeus Group•Fridley, MN

6d•Onsite

About The Position

The primary responsibility of the Quality Design Assurance Senior Engineer position is to lead project team members supporting the development of complex medical device components, assemblies, and systems. This role represents the Quality Assurance function on multiple product and process development projects, working cross-functionally to ensure development activities comply with applicable regulatory requirements, customer requirements, quality standards, and Quality Management System procedures. The Quality Design Assurance Senior Engineer operates with a high degree of independence, technical judgment, and collaboration, supporting design controls, risk management, verification and validation activities, and design transfer to manufacturing to ensure robust, manufacturable, and compliant medical device products. This is an onsite position in our Fridley, MN location, but could require movement between this and the White Bear Lake, MN location.

Requirements

Bachelor degree in engineering or related field required
Minimum 8 years of relevant experience required.
1 year of relevant experience may be substituted for a graduate degree or 3 years for a doctorate.
Experience 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 and familiarity with ISO 13485, FDA Quality System Regulations, Design Controls, Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), ISO 14971, sterilization processes, cleanroom environments, and other applicable standards.
Customer-focused mindset with the ability to work collaboratively across functional groups.
Must be highly organized and able to manage multiple projects concurrently.
Strong independent problem-solving skills and active work to coach others in this area.
Must possess strong written and verbal communication skills, team-building skills, and basic PC skills, including working knowledge of Microsoft Word, Excel, and Minitab.
Must be able to read and interpret component and product specifications.
Must be willing and able to travel between Fridley, MN and White Bear Lake, MN sites, as needed.

Nice To Haves

Master’s degree in Engineering or related technical field preferred.
Preferred practical knowledge related to the products supported by the position, such as guidewires, catheters, leads, electromechanical devices, or related technologies.

Responsibilities

Serve as the primary Quality Assurance Engineer on complex product and process development projects, collaborating across cross‑functional teams to drive deliverables through the Product and Process Development Process while ensuring documentation accuracy, completeness, and compliance.
Lead Quality Assurance development activities by creating and maintaining Quality Plans, requirements traceability, and Risk Management Plans, and by reviewing/approving Change Orders, Deviations, Verification/Validation protocols, qualification reports, and inspection procedures in alignment with design controls and QMS requirements.
Design and/or specify inspection strategies, test plans, procedures, and systems to ensure products meet specifications, regulatory requirements, customer needs, and quality standards, while providing periodic updates on quality status and development progress.
Initiate, review, and approve Nonconforming Product dispositions; investigate in‑house nonconformances across components, assemblies, and finished devices; perform root‑cause analysis; implement corrective actions; and monitor quality trends and complaint trends in collaboration with Regulatory Affairs.
Lead and support continuous improvement initiatives, including proposing solutions, utilizing the CAPA system, improving product quality, process robustness, and manufacturability, and contributing to enhancements in quality systems, processes, and documentation.
Support and interface with engineering, manufacturing, regulatory, quality, and operations teams to promote collaboration, maintain compliance with the Quality Management System (QMS), reduce operational risk, and provide input for Quality Management Reviews.
Facilitate customer audits and assist with external audits such as FDA and ISO inspections, ensuring readiness and alignment with regulatory expectations and complaint handling requirements.
Provide mentorship and technical guidance to Quality Assurance Technicians and junior engineers; develop and monitor quarterly quality goals and objectives; and participate in company meetings, training sessions, and quality improvement initiatives.
Other duties may be assigned as required.