Work Shift: DAY Work Schedule: 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.ESSENTIAL FUNCTIONS PERFORMEDParticipates in design and development activities assuring the design outputs are appropriately transferred into manufacturingGuides the design team through Process Validation, Test Method Validation and Device Master Record creationResponsible for coordinating process risk analysis/management activities. This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvementsReviews, 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 techniquesPerforms 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 projectContributes techniques which are of material significance to solve specific problems and drive continuous improvementKeeps 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 developmentsMay plan, organize, and mentor the work of engineers or technicians on various engineering projects and quality system compliance issuesReviews nonconformance records (internal/external) to determine disposition, root cause,



and need for corrective and preventive actionsEnsures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended useIdentifies 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, etcEvaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controlsPerforms a variety of other tasks and related work, as requiredESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDSLifting – Not to exceed 50 lbs. – local practice may applyWritingSittingStandingBendingVisual acuityColor perceptionDepth perceptionReadingField of vision/peripheralSUMMARY OF MINIMUM QUALIFICATIONSEducation and/or experience equivalent to a Bachelor's Degree in Engineering or related fieldDemonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standardsWorking 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 experienceKnowledge of applicable regulatory agency regulationsDemonstrated computer skills, preferably spreadsheets, word processing, database,



and other applicable software programsPREFERRED QUALIFICATIONSMedical device experience or equivalent experience in a regulated industryExperience with Minitab and OraclePassed ASQ Certified Quality Engineering examCOMPETENCIESInterpersonal skillsOrganizationWritten and Verbal CommunicationTeamworkConflict ResolutionProblem SolvingDecision MakingComments Infectious Control Risk Category II: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.As an eligible Merit employee, you can expect the followingMultiple Shifts and Hours to choose from: Days, Swing (Eve), and NightsMedical/Dental & Other Insurances (eligible the first of month after 30 days)Low Cost Onsite Medical ClinicTwo (2) Onsite CafeteriasEmployee Garden | Gardening Classes3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays401K | Health Savings AccountMerit employs approximately 6,000 people worldwide with facilities in South Jordan, Utah; Pearland, Texas; Richmond, Virginia; Aliso Viejo, California; Maastricht and Venlo, The Netherlands; Paris, France; Galway, Ireland; Beijing, China; Tijuana, Mexico; Joinville, Brazil;Ontario, Canada; Melbourne, Australia; Tokyo, Japan; Reading, United Kingdom; Johannesburg, South Africa; and Singapore.Founded in 1987, Merit Medical Systems, Inc. is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit serves client hospitals worldwide with a domestic and international sales force and clinical support team totaling in excess of 500 individuals.Merit Medical is a leading manufacturer and marketer of proprietary disposable medical devices used in interventional, diagnostic and therapeutic procedures, particularly in cardiology, radiology, oncology, critical care and endoscopy. Merit has made it a priority to understand customers, innovate, and deliver life-changing products and services.#J-18808-Ljbffr

📌 Qa Design Transfer Engineer I/Ii (Tijuana)
🏢 Merit Medical Systems
📍 Tijuana