Principal QA Design Transfer Engineer

Merit Medical Systems - South Jordan, UT

Full-time - Principal

South Jordan, UT

5,001-10,000 employees

Merchant Wholesalers, Durable Goods

About the position

The Principal QA Design Transfer Engineer at Merit Medical is responsible for providing extensive quality engineering support for medical device products and processes, particularly during design transfer activities. This role involves ensuring compliance with quality requirements, optimizing quality systems, and mentoring engineering teams to uphold quality standards throughout product development and manufacturing processes.

Responsibilities

• Participates in design and development activities to ensure design requirements are effectively transferred into manufacturing.
• Coordinates risk analysis and management activities, leading meetings and documenting results for risk mitigation.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) for verification, validation, and inspection methods.
• Conducts studies to address complex technical problems using sophisticated research techniques.
• Mentors and evaluates the competency of Quality Auditors and Design Assurance/Quality Engineers.
• Reviews nonconformance records to determine root cause and corrective actions.
• Ensures containment of nonconforming products to prevent unintended use.
• Implements changes to maintain the effectiveness of the quality management system.
• Evaluates the manufacturing work environment to ensure adequate controls and safety measures are in place.
• Supports internal and supplier audit activities.

Requirements

• Bachelor's Degree in Engineering or related field.
• Fifteen (15) years of engineering experience.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and other medical device standards.
• Experience with statistical methodologies and quality control tools such as Six Sigma and lean manufacturing.
• Demonstrated computer skills, including spreadsheets and databases.

Nice-to-haves

• Medical device experience or equivalent in a regulated industry.
• Experience with Minitab or JMP, Oracle.
• Passed ASQ Certified Quality Engineering exam.

Benefits

• Medical/Dental & Other Insurances (eligible the first of month after 30 days)
• Low Cost Onsite Medical Clinic
• Two (2) Onsite Cafeterias
• Employee Garden | Gardening Classes
• 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays
• 401K | Health Savings Account