Position Overview
The Senior Software Quality Engineer is responsible for performing design assurance activities for new introductions and sustaining of medical device software, with the purpose of supporting the Software R&D;, Test and Manufacturing departments. The incumbent for this position will support the Software Development Lifecycle of one or more projects from concept generation through production. This person will work closely with software design, software testing, project management, product management, regulatory, human factors, and manufacturing teams to understand and influence the architecture, requirements, detail design, testing, safety and cybersecurity risk evaluation and deployment of the software designs to the market.

This person must be versatile to support other design assurance activities such as data analysis, problem solving/ failure analysis, full QMS compliance and alignment with the software development practices, Business Process Optimization initiatives and continuous improvement to the Quality Management System. Additionally,



this person must be able to perform as a Quality Assurance representative for hardware and disposable‑related projects to support system‑level reliability improvements when needed. They also help guide and mentor other team members in a collaborative environment.

Essential Job Functions and Responsibilities
- Work closely with Regulatory, R&D;, Test and Manufacturing, to ensure the adoption and use of best practices, Quality tools, and Design Control methodologies
- Support Software Quality Assurance (SQA) strategy and operational execution plans
- Knowledge of and experience in developing and medical devices in conformance with Quality System Regulations, ISO13485, ISO14971, ISO62304 and SW96 requirements.
- Applies knowledge of IEC 62304 to product development and sustaining engineering projects.
- Engage with the development team to align best practices and techniques for automated unit and integration test

📌 Senior Software Quality Engineer (Tijuana)
🏢 Outset Medical
📍 Tijuana