Senior QA Design Transfer Engineer I

200 Merit Maquiladora Mexico, S. DE R.L. DE C.V.; Tijuana; Presencial; MXN 600.000 - 1.200.000; Jornada completa

Descripción de la vacante

Merit Medical Systems, Inc. in Tijuana, Mexico, seeks an experienced engineering leader to drive design control, transfer requirements to manufacturing, and ensure compliance with medical device standards.

The role emphasizes risk management, change control, process validation, and mentoring engineers, with opportunities across multiple shifts and a strong focus on quality and continuous improvement.

Formación

• Education/experience equivalent to a Bachelor's in Engineering with 8+ years in engineering.
• Experience with 21 CFR 820, ISO13485, and medical device standards.
• Strong knowledge of statistics, lean manufacturing, Six Sigma, and quality systems.
• Experience leading risk management and ECN processes.

Responsabilidades

• Guide design transfer of requirements into manufacturing and document DMR.
• Lead risk management activities and ensure mitigation.
• Review and generate ECNs for verification, validation, monitoring and test methods.
• Mentor quality auditors and engineers; drive corrective/preventive actions.

Conocimientos

Design Control

Risk Analysis

ECNs

Process Validation

Root Cause Analysis

Problem Solving

Quality Systems

Team Mentoring

Regulatory Knowledge

Written Communication

Educación

Bachelor's Degree in Engineering

Herramientas

Minitab

JMP

Oracle

Descripción del empleo

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 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.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

• Lifting -- Not to exceed 50 lbs. – local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field. A minimum of eight (8) years of engineering experience. Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. Working 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. Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs.

PREFERRED QUALIFICATIONS

Medical device experience or equivalent experience in a regulated industry. Experience with Minitab or JMP, Oracle. Passed ASQ Certified Quality Engineering exam.

COMPETENCIES

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

COMMENTS

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 following:

• 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

To see more on our culture, go to www.merit.com/careers.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.

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 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.

UNDERSTAND. INNOVATE. DELIVER.

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.