Principal QA Design Transfer Engineer

100 Merit Medical Systems, Inc. - South Jordan, UT

Full-time - Senior

South Jordan, UT

5,001-10,000 employees

About the position

The Quality Engineer at Merit Medical is responsible for providing extensive quality engineering support for medical device products and processes. This role involves ensuring compliance with quality requirements throughout the product development lifecycle, from design transfer to risk management. The engineer will work closely with design teams, coordinate risk analysis, and contribute to continuous improvement initiatives, all while mentoring junior engineers and ensuring the effectiveness of the quality management system.

Responsibilities

• Participates in design and development activities to ensure design requirements are transferred into manufacturing.
• Guides the design team as a subject matter expert in Design Control from Design Inputs through Design Outputs.
• Coordinates risk analysis and management activities, leading meetings and documenting results.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) for verification and validation methods.
• Conducts studies to address technical problems requiring novel approaches and sophisticated research techniques.
• Contributes techniques to solve specific problems and drive continuous improvement.
• Keeps abreast of new scientific methods and regulations to recommend process changes.
• Mentors and supervises engineers or technicians on engineering projects and quality compliance issues.
• Evaluates competency of Quality Auditors and Design Assurance Engineers through training and assessments.
• 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 for adequate controls and safety measures.
• Supports internal and supplier audit activities, writing reports and following up on corrective actions.

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.
• Knowledge of 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

• Multiple shifts and hours to choose from: Days, Swing (Eve), and Nights
• 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