Senior QA Design Transfer Engineer I - South Jordan, UT

Job Title

Why Merit? At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

Work Shift: DAY (United States of America)

Summary of Duties:

Provides quality engineering support for products and processes while completing projects in broad areas of assignment supporting design transfer activities. Fulfills requirements associated with product development, design controls, and product risk management. Ensures that the products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.

Essential Functions Performed:

• Participates in design and development activities assuring the design requirements are appropriately transferred into manufacturing. Guides the design team as subject matter expert of Design Control from Design Inputs through Design Outputs, Process Validation, Test Method Validation and Device Master Record creation.
• Responsible for coordinating risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s).
• Conducts complete and conceptually related studies to approach technical problems, where the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques.
• Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project.
• Contributes techniques which are of material significance to solve specific problems and drive continuous improvement.
• Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments.
• May plan, organize and mentor engineers or technicians on various engineering projects and quality system compliance issues.
• Mentors and evaluates competency of Quality Auditors, Design Assurance/Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives.
• Reviews nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions.
• Ensures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use.
• Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, risk management, etc.
• Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls.
• May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions.
• Performs a variety of other tasks and related work, as required.

Equal Opportunity Employer M/F/D/V. Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled