Senior Software Test Engineer leading testing for embedded software systems in medical devices. Focused on manual and automated testing, compliance, and collaboration with QA teams.
Responsibilities
Design and execute manual and automated test strategies for embedded applications
Collaborate with onshore and offshore QA teams for global test execution
Develop and maintain manual and automated test cases for embedded software
Perform functional, regression, performance, stress, and reliability testing
Ensure compliance with industry standards and internal quality benchmarks
Create and update Trace matrices between requirements and Tests
Mentor junior QA engineers and contribute to continuous improvement of QA processes
Participate in Agile/Scrum ceremonies and contribute to sprint planning and retrospectives
Requirements
5+ years of experience in embedded software testing
Strong mix of manual and automation testing
At least 2+ years in medical device software testing
Familiarity with SDLC, test lifecycle, and Agile methodologies
Proficiency in Python, Jenkins, and test automation tools
Experience working with products from the prototype through 510(k)/ISO clearance
Thorough understanding of software quality assurance principles and practices
Proven record developing and executing software test protocols for complex medical devices
Familiarity with IEC 62304, ISO 14971, FDA 21 CFR Part 820 standards
Strong analytical and problem-solving skills
Excellent communication and documentation abilities
Benefits
Hybrid working arrangements
On-site work required from Insulet office
Job title
Senior Software Test Engineer – Embedded Software, Manual & Automation
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