Senior QA Design Transfer Engineer – Medical Devices

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

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.