Senior Medical Device Software Quality Engineer

Outset Medical; Tijuana; Presencial; MXN 1.216.333 - 1.737.619; Jornada completa

Descripción de la vacante

Outset Medical in Tijuana, Baja California is seeking a Senior Software Quality Engineer. This role focuses on ensuring quality assurance for medical device software throughout the Software Development Lifecycle. Candidates must have a Bachelor's degree in Computer or Engineering Science, with at least 5 years of hands-on Quality Engineering experience in the medical device field. Knowledge of FDA regulations and ISO standards is critical. A collaborative attitude and strong communication skills are essential in this role.

Formación

• Minimum of 5 years of hands-on experience in Quality Engineering.
• Prior experience in the medical device field is required.
• Ability to communicate fluently in written and spoken English.

Responsabilidades

• Support Software Quality Assurance (SQA) strategy and operational plans.
• Collect, analyze, and communicate quality data.
• Lead / Contribute to safety and cybersecurity risk management.

Conocimientos

Quality Engineering

Medical Device Knowledge

Problem Solving

Data Analysis

Leadership

Communication Skills

Educación

Bachelor's degree in Computer or Engineering Science

Master's degree preferred

Herramientas

ISO 13485

ISO 14971

ISO 62304

FDA Regulations

Descripción del empleo

Outset Medical in Tijuana, Baja California is seeking a Senior Software Quality Engineer. This role focuses on ensuring quality assurance for medical device software throughout the Software Development Lifecycle. Candidates must have a Bachelor's degree in Computer or Engineering Science, with at least 5 years of hands-on Quality Engineering experience in the medical device field. Knowledge of FDA regulations and ISO standards is critical. A collaborative attitude and strong communication skills are essential in this role.