QA Design Transfer Engineer I​/II - South Jordan, UT

Job Summary

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 optimizes quality systems and documentation.

• Participates in design and development activities ensuring design outputs are transferred into manufacturing.
• Guides the design team through process validation, test method validation, and Device Master Record creation.
• Coordinated process risk analysis and management activities, including leading risk management meetings and documenting results.
• Reviews, approves, and generates Engineering Change Notifications (ECNs) to update verification, validation, monitoring, and inspection methods, procedures, and test protocols for assigned product lines and processes.
• Conducts complete and conceptually related studies to approach technical problems requiring unconventional or novel solutions.
• Performs technical work where existing guides contain critical gaps or are largely lacking due to novel project character.
• Contributes techniques that are materially significant to solve specific problems and drive continuous improvement.
• Keeps abreast of new scientific methods and regulations to recommend changes to processes, systems or designs.
• May plan, organize, and mentor engineers or technicians on engineering projects and quality system compliance issues.
• Reviews nonconformance records to determine disposition, root cause, and need for corrective and preventive actions.
• Ensures containment of nonconforming product to prevent unintended use.
• Identifies and implements changes needed to maintain the suitability and effectiveness of the quality management system.
• Evaluates the manufacturing environment to ensure it is adequately controlled and monitored.
• Performs other tasks and related work as required.

• Lifting not to exceed 50 lbs.
• Writing, sitting, standing, bending, visual acuity, color perception, depth perception, reading, field of vision/peripheral.

• Bachelor's Degree in Engineering or related field.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14791, and other medical device related standards.
• Knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience.
• Knowledge of applicable regulatory agency regulations.
• Computer skills, preferably spreadsheets, word processing, database and other applicable software programs.

• Medical device experience or equivalent regulated industry experience.
• Experience with Minitab and Oracle.
• Passed ASQ Certified Quality Engineering exam.

• Interpersonal skills
• Organization
• Written and Verbal Communication
• Teamwork
• Conflict Resolution
• Problem Solving
• Decision Making

• Multiple shifts and hours to choose from: days, swing (evening), 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.
• Three weeks vacation, one week sick time, paid holidays.
• 401(k) and health savings account.

Merit is a proud Utah Patriot Partner committed to hiring veterans. Military veterans are encouraged to apply.