Senior Medical Device Software Quality Engineer

Outset Medical, Inc.; Mexico; On-site; MXN 600,000 - 900,000; Full time

Job summary

Outset Medical, Inc. is seeking a Senior Software Quality Engineer to drive design assurance for software across major medical device programs. You will collaborate with Regulatory, R&D, Test and Manufacturing to influence architecture, requirements, and risk management throughout the SDLC.

You will lead quality activities for software, hardware, and disposables, support CAPA and audits, and mentor team members while ensuring compliance with FDA/ISO standards.

Qualifications

• Bachelor's degree in Computer or Engineering Science (or similar) required; Master's preferred.
• Minimum 5 years hands-on experience in the Quality Engineering discipline.
• Prior experience in the medical device field is required; preferably with embedded software/digital health initiatives.
• Ability to work effectively in a fast paced and dynamic environment.

Responsibilities

• Collaborate with Regulatory, R&D, Test and Manufacturing to implement Design Control methodologies.
• Support SQA strategy and execution plans.
• Ensure conformance to FDA QSR, ISO 13485, ISO 14971, ISO 62304 and SW96 requirements.
• Lead risk management activities and safety/cybersecurity planning and reporting.
• Develop and execute software verification and validation plans and test reports.

Skills

Quality engineering

Regulatory liaison

Project management

Software quality assurance

Root cause analysis

Communication skills

Education

Bachelor's degree in Computer or Engineering Science

Master's degree preferred

Tools

Defect tracking system

Statistical analysis software

Risk management tools

Job description

Outset Medical, Inc. is seeking a Senior Software Quality Engineer to drive design assurance for software across major medical device programs. You will collaborate with Regulatory, R&D, Test and Manufacturing to influence architecture, requirements, and risk management throughout the SDLC.

You will lead quality activities for software, hardware, and disposables, support CAPA and audits, and mentor team members while ensuring compliance with FDA/ISO standards.