Senior Design Assurance Quality Engineer I- South Jordan, UT

Merit Medical Systems - South Jordan, UT

Full-time - Senior

Onsite - South Jordan, UT

Merchant Wholesalers, Durable Goods

About the position

The Senior Design Assurance Quality Engineer at Merit Medical is responsible for providing comprehensive design assurance and quality engineering support for medical device products and processes. This role involves ensuring compliance with quality requirements throughout the product development lifecycle, including design controls, risk management, and usability engineering. The engineer will work closely with research and development teams to guide design processes and implement quality systems, ultimately contributing to the creation of innovative medical devices that improve patient lives.

Responsibilities

• Participates in design and development activities ensuring design requirements are met with quality engineering approaches.
• 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 complex technical problems requiring novel approaches.
• Performs technical work where guides and precedents may be lacking due to the novel nature of projects.
• Contributes techniques to solve specific problems and drive continuous improvement.
• Stays updated on new scientific methods and regulations to recommend process changes.
• May mentor and supervise engineers or technicians on engineering projects and quality compliance.
• Mentors and evaluates competency of Quality Auditors and Design Assurance 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 for adequate control and monitoring.
• Supports internal and supplier audit activities, writing reports and following up on corrective actions.
• Performs other related duties as required.

Requirements

• Bachelor's Degree in Engineering or related field.
• Six years of design assurance/quality engineering experience.
• Working knowledge of 21 CFR 820, ISO13485, ISO14791, and other medical device standards.
• Knowledge of statistical methodologies and quality control tools such as Six Sigma.
• Familiarity with applicable regulatory agency regulations.
• Demonstrated computer skills, including spreadsheets and database software.

Nice-to-haves

• Medical device experience or equivalent in a regulated industry.
• Experience handling deviations, investigations, and CAPAs.
• 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 Onsite Cafeterias
• Employee Garden and Gardening Classes
• 3 Weeks' Vacation and 1 Week Sick-Time
• Paid Holidays
• 401K and Health Savings Account