Senior Engineer - Quality Design Assurance

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

Benefits offered by this job

Medical, dental, vision coverage

401(k) with company match

Education reimbursement

Parental leave

Paid time off

Job summary

Heraeus Medevio is seeking a Quality Design Assurance Senior Engineer to lead QA activities on complex medical device projects. You will drive design controls, risk management, and verification/validation, ensuring robust, manufacturable products and compliance with QMS requirements.

This onsite role in Fridley, MN may require travel to White Bear Lake. You will mentor QA technicians and partner with engineering, regulatory, and operations to uphold high quality standards across development

Qualifications

• Bachelor degree in engineering or related field required.
• Experience in medical device industry as a Quality Assurance Engineer strongly preferred.
• Experience with ISO 13485, FDA QSR, Design Controls, GMP/GLP, ISO 14971.

Responsibilities

• Serve as the primary QA Engineer on complex product and process development projects.
• Lead QA development activities by creating Quality Plans, Traceability, and Risk Management Plans.
• Design and specify inspection strategies, test plans, and systems to meet specs and regulatory requirements.
• Initiate, review, and approve Nonconforming Product dispositions; perform root-cause analysis; implement corrective actions.
• Lead continuous improvement initiatives using CAPA and quality systems enhancements.
• Collaborate with engineering, manufacturing, regulatory, quality, and operations teams to maintain QMS compliance.
• Facilitate customer audits and assist with FDA/ISO inspections.
• Provide mentorship to QA Technicians and junior engineers; participate in training and quality improvement initiatives.
• Other duties as required.

Skills

Quality Assurance

Cross-functional collaboration

Documentation accuracy

Root-cause analysis

Problem-solving

Mentorship

Education

Bachelor degree in engineering

Master’s degree preferred

Tools

Minitab

Inspection tools

Test equipment

Job description

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.

Heraeus is proud to be an employer that provides equal access to opportunities for all its employees. We provide fair and equal consideration to all qualified applicants, regardless of sex, gender identity, sexual orientation, race, color, religion, national origin, physical or mental disability, protected veteran status, age, or any other legally protected characteristic. A diverse and inclusive culture is at the heart of our Vision, Mission, and Values. We are dedicated to cultivating a workforce that reflects a broad spectrum of cultures, backgrounds, and perspectives.

We participate in E-Verify to confirm employment eligibility after hire. Learn more at www.e-verify.gov