Senior Engineer - Quality Design Assurance

Heraeus Holding GmbH; Fridley (MN); On-site; USD 110,000 - 130,000; Full time

Job summary

Heraeus Medevio seeks a Senior Engineer in Quality Design Assurance to lead QA efforts on complex medical device development programs. The role includes design controls, risk management, verification/validation, and transfer to manufacturing to ensure robust, compliant products.

Onsite in Fridley, MN with possible moves to White Bear Lake, MN. You will mentor QA technicians, develop quarterly quality goals, and drive CAPA processes while collaborating across engineering, regulatory, and

Qualifications

• Bachelor degree in engineering required.
• 8+ years of relevant experience in medical device QA.
• Experience with ISO 13485, FDA QSR, GMP, ISO 14971.
• Willingness to travel between Fridley and White Bear Lake.

Responsibilities

• Serve as the primary QA engineer on complex product and process development projects with cross‑functional teams.
• Lead QA activities by creating quality plans, requirements traceability, and risk management plans.
• Review/approve change orders, deviations, verification/validation protocols, and IQ/OQ/PQ docs.
• Design/specify inspection plans and test procedures to meet specs and regulatory needs.
• Initiate, review and disposition nonconforming product; perform root-cause analysis and corrective actions.
• Support continuous improvement, CAPA, and quality system enhancements.
• Collaborate with engineering, manufacturing, regulatory, quality and operations to ensure QMS compliance.
• Facilitate customer and external audits (FDA/ISO) and mentor QA staff.

Skills

Quality Assurance

Design Controls

Risk Management

Verification & Validation

CAPA

Regulatory Compliance

Cross-functional collaboration

Documentation

Education

Bachelor degree in engineering

Master's degree in Engineering

Tools

Gages

Inspection tools

Test equipment

Minitab

Excel

Job description

Senior Engineer - Quality Design Assurance

Permanent

About Heraeus

Making displays foldable? Helping hearts beat with medical innovations? Or breathing new life into precious metals? As a family‑owned global technology group we help our customers to always being one step ahead.

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, 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.

Position Summary

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.

What You’ll Do Every Day:

• 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.

What We’re Looking For:

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

Medevio is committed to providing competitive total compensation and benefits packages. The expected hiring range for this position is between $110,000 and $130,000 based upon a full‑time schedule. This is a good faith estimate on the applicable range.Base salaries are determined by taking a variety of factors in account, including, but not limited to, candidate qualifications, geographic locations, market conditions and internal equity.This position is bonus eligible, with a target bonus of 10%.Our total compensation package includes eligibility for comprehensive medical, dental, and vision coverage, a 401(k) plan with company match, education reimbursement, paid parental leave and paid time off.