Senior QA Design Assurance Engineer - Medical Devices

Heraeus Medevio; Fridley (MN); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

Bonus eligibility (target 10%)

Medical, dental, vision

401(k) with company match

Education reimbursement

Paid parental leave

Paid time off

Job summary

Heraeus Medevio in Fridley, MN is seeking a Quality Design Assurance Senior Engineer to lead QA activities on complex medical device development projects. The role covers design controls, risk management, verification/validation, and design transfer to manufacturing to ensure robust, compliant products.

The position is onsite in Fridley, MN with potential movement to White Bear Lake and requires collaboration across engineering, regulatory, and operations. Travel may be required.

Qualifications

• Bachelor degree in engineering or related field; master’s degree preferred.
• 8 years of relevant experience; 1 year may be substituted for a graduate degree or 3 years for a doctorate.
• Experience in the medical device industry as a Quality Assurance Engineer preferred.
• Familiar with ISO 13485, FDA QSR, Design Controls, GMP/GLP, ISO 14971, sterilization processes, and cleanrooms.
• Strong written and verbal communication; customer-focused and collaborative.
• Willing to travel between Fridley and White Bear Lake sites.

Responsibilities

• Serve as the primary QA Engineer on complex product and process development projects across cross‑functional teams.
• Lead QA development activities with Quality Plans, traceability, and Risk Management; review/approve change orders, deviations, and verification/validation protocols.
• Design and specify inspection strategies, test plans, and procedures to meet specs and regulatory requirements.
• Initiate, review, and approve nonconforming product dispositions; perform root-cause analysis and corrective actions; monitor quality trends.
• Lead continuous improvement initiatives via CAPA to improve quality and manufacturability.
• Support engineering, manufacturing, regulatory, quality, and operations to uphold QMS and participate in audits.
• Mentor QA Technicians and junior engineers; set quarterly quality goals; participate in training and quality initiatives.
• Other duties as required.

Skills

Customer-focused mindset

Highly organized

Independent problem-solving

Written and verbal communication

Team-building

Travel between sites

Education

Bachelor's degree in engineering or related field

Master’s degree in Engineering or related field preferred

Tools

Microsoft Word

Excel

Minitab

Job description

Heraeus Medevio in Fridley, MN is seeking a Quality Design Assurance Senior Engineer to lead QA activities on complex medical device development projects. The role covers design controls, risk management, verification/validation, and design transfer to manufacturing to ensure robust, compliant products.

The position is onsite in Fridley, MN with potential movement to White Bear Lake and requires collaboration across engineering, regulatory, and operations. Travel may be required.