Senior Engineer - Quality Design Assurance

Heraeus is a family-owned global technology group that helps customers stay ahead through innovations in medical devices, precious metals, and other advanced technologies. Heraeus Medevio, a division of Heraeus Group, focuses on bringing lifesaving and life-changing medical devices to market through partnerships with medical device manufacturers. With over 2,200 employees across the United States, European Union, and Asia, we foster a culture of curiosity, continuous learning, and growth to improve 100 million lives every year.

About the role

The Quality Design Assurance Senior Engineer leads project teams in the development of complex medical device components, assemblies, and systems. This role represents Quality Assurance on multiple product and process development projects, ensuring compliance with regulatory requirements, customer needs, quality standards, and Quality Management System (QMS) procedures. The position operates with a high degree of independence and technical judgment, supporting design controls, risk management, verification, validation, and design transfer to manufacturing. This is an onsite role based in Fridley, MN, with potential movement to the White Bear Lake, MN location.

Responsibilities

• Serve as the primary Quality Assurance Engineer on complex product and process development projects, collaborating with 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. Review and approve 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. Provide 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 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 QMS compliance, 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.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree in engineering or a related field required; master’s degree in Engineering or a related technical field preferred.
• Minimum 8 years of relevant experience required. One year of relevant experience may be substituted for a graduate degree or 3 years for a doctorate.
• For Engineer III level: bachelor’s degree in Engineering or related technical field strongly preferred; other relevant postsecondary education, training, and experience may be considered in lieu of a Bachelor’s degree with a minimum of 5 years of relevant experience.
• 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.
• Highly organized with the ability to manage multiple projects concurrently.
• Strong independent problem-solving skills and a willingness to coach others in this area.
• Preferred practical knowledge related to guidewires, catheters, leads, electromechanical devices, or related technologies.
• Strong written and verbal communication skills, team-building skills, and basic PC skills, including working knowledge of Microsoft Word, Excel, and Minitab.
• Ability to read and interpret component and product specifications.
• Willingness and ability to travel between Fridley, MN and White Bear Lake, MN sites as needed.

Benefits

• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with company match.
• Education reimbursement.
• Paid parental leave and paid time off.

Pay

The expected hiring range for this position is between $100,000 and $130,000 annually for a full-time schedule, based on candidate qualifications, geographic location, market conditions, and internal equity. This position is bonus eligible, with a target bonus of 10%.