Senior QA Design Transfer Engineer - Design Controls Expert

Merit Medical Systems, Inc.; Tijuana; Presencial; MXN 2.080.804 - 3.121.207; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical/Dental

Onsite Medical Clinic

3 Weeks Vacation

401K

Descripción de la vacante

Merit Medical Systems, Inc. is seeking an experienced engineer to lead Design Control activities for medical devices. You will guide cross-functional teams, manage risk analyses, and drive improvements across verification, validation, and change control processes.

Ideal candidates have a strong background in Quality Systems, 21 CFR 820, ISO 13485, and lean/Six Sigma practices, with at least eight years in engineering and project management within regulated environments.

Formación

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
• A minimum of eight (8) years of engineering experience.
• Working knowledge of 21 CFR 820 and ISO 13485 among medical device standards.
• Experience with quality control tools, problem solving, root cause investigation, lean manufacturing, and Six Sigma.
• Knowledge of regulatory agency regulations and project management.

Responsabilidades

• Guide the design team as SME of Design Control from inputs to outputs and device master records.
• Coordinate risk analysis/management activities and drive risk mitigation.
• Review and generate ECNs to update verification/validation and test protocols.
• Conduct studies to solve novel technical problems and drive continuous improvement.
• Mentor engineers and technicians on quality system compliance and audits.
• Support internal and supplier audits and ensure corrective/preventive actions.

Conocimientos

Design Control

Risk Analysis

ECN leadership

Quality Systems

Problem Solving

Lean/Six Sigma

Statistical methods

Educación

Bachelor's Degree in Engineering

Herramientas

Minitab

JMP

Oracle

Descripción del empleo

Merit Medical Systems, Inc. is seeking an experienced engineer to lead Design Control activities for medical devices. You will guide cross-functional teams, manage risk analyses, and drive improvements across verification, validation, and change control processes.

Ideal candidates have a strong background in Quality Systems, 21 CFR 820, ISO 13485, and lean/Six Sigma practices, with at least eight years in engineering and project management within regulated environments.