Design Assurance Engineer
Location: San Francisco Bay Area, CA
Full Time
Role Overview
As the Design Assurance Engineer, you will be responsible for driving the testing and automating product updates, OS updates, and security features for medical devices to meet FDA and ISO13485 regulatory requirements – championing product quality and regulatory compliance throughout the way.
The day-to-day of the role will consist of reviewing product description documents, creating test plans, creating automation for QT based GUI applications, gRPC interfaces, testing custom Linux and Window OS configurations.
Must be a self-starter, able to operate with remote teams, in a fast-paced environment.
Responsibilities
Review product requirements and design test plans for execution.
Ensure all testing procedures comply with internal and external standards.
Perform manual and automated testing on a Linux system.
Design and maintain test automation using Python for Verification and Validation.
Manage product specifications, including change control.
Qualifications
Proficiency in Python.
Solid understanding of Ubuntu-based Linux OSs.
Solid understanding of GIT version control.
Solid understanding of QA practices coupled with the ability to write detailed bug reports.
Solid understanding of OS virtualization and running virtual machines.
Familiarity with embedded systems and electronics.
Experience running and creating Docker containers.
Proficiency with Jira, Confluence, or similar project tracking tools.
Intense proficiency in authoring testing procedures and reports that meet Quality Management System (QMS) requirements, ensuring compliance and verification for medical devices.
Prior experience in a startup or fast-paced medical device R&D environment.
Preferred Qualifications
Solid understanding of Qt SDK.
Solid understanding of Secure Boot mechanisms.
Experience with Jenkins CI/CD pipeline.
Experience in NPI test design and creation.
Experience with HIL test automation.
Ultrasound experience is a plus.
Ability to design tests for validation of medical devices.