Job Overview
As a Senior Software Quality Engineer, you will play a critical role in ensuring the quality and safety of our medical device software. You will be responsible for designing, implementing, and executing comprehensive test strategies to validate and verify software functionality, performance, and security.
Key Responsibilities:
Test Planning:
- Develop comprehensive test plans and test cases based on software requirements specifications.
- Identify test scenarios and test data to ensure thorough coverage.
Test Execution:
- Execute test cases manually or using automated tools.
- Retest fixed defects to verify resolution.
Test Automation:
- Develop and maintain automated test scripts using tools like Squish, Python and Selenium.
- Create and execute automated test suites to improve efficiency and test coverage.
- Integrate automated software testing on hardware systems
Defect Tracking and Management:
- Prioritize, categorize, and track defects.
- Collaborate with development teams to resolve defects.
Risk Analysis:
- Identify potential risks and vulnerabilities in the software.
- Develop mitigation strategies to minimize risks.
Regulatory Compliance:
- Ensure compliance with FDA, IEC 62304, and other relevant regulations.
- Participate in design reviews and risk analysis activities.
- Ensure proper analysis and documentation of test results.
Security Testing:
- Conduct security testing, including penetration testing and vulnerability assessments.
- Ensure compliance with security standards and guidelines.
Usability Testing:
- Collaborate with UX designers to ensure software usability and user experience.
- Conduct usability tests to identify usability issues.
Performance Testing:
- Perform performance testing to evaluate system response time and resource utilization.
- Identify and resolve performance bottlenecks.
Process Improvement:
- Continuously improve testing processes and methods.
- Identify opportunities for automation and efficiency gains.
- Integrate testing with continuous-integration process.
- Use test automation techniques (data driven, pairwise, mocking, test hooks) that fit the problem space.
Collaboration with Development Teams:
- Work closely with development teams to understand requirements and design.
- Provide timely feedback on code quality and testability.
- Work with the team to define, build and maintain the test infrastructure and environments.
Qualifications:
Technical Skills:
- Software Testing: Proficiency in various testing methods (unit, integration, system, acceptance) and techniques (black-box, white-box, grey-box).
- Test Automation: Expertise in automation frameworks like Squish, Bitbucket Pipelines, Selenium.
- Programming Languages: Strong proficiency in C++, Python, with familiarity in JavaScript, CUDA and Gherkins.
- Development Frameworks: Experience in Qt/QML, React, CUDA.
- Database Testing: Knowledge of database testing techniques and tools (e.g., SQL, NoSQL).
- CUDA and GPU Programming: Knowledge of parallel programming concepts and CUDA for GPU-accelerated applications.
- Medical Device Regulations: Deep understanding of medical device regulations, including FDA, IEC 62304, and ISO 13485.
Soft Skills:
- Problem-solving: Ability to identify, analyze, and resolve complex technical issues.
- Analytical Thinking: Strong analytical skills to evaluate test results and identify potential problems.
- Attention to Detail: Meticulous attention to detail to ensure thorough testing and accurate reporting.
- Communication Skills: Effective communication with developers, project managers, and other stakeholders.
- Teamwork: Ability to collaborate effectively with cross-functional teams.
- Adaptability: Willingness to learn new technologies and adapt to changing requirements.
Qualifications+:
Technical Skills:
- Cloud Platforms: Experience with GCP and Atlassian Bitbucket for deployment and testing.
- CI/CD Pipelines: Proficiency in setting up and maintaining CI/CD pipelines using Bitbucket Pipelines.
- Security Testing: Deep understanding of security testing methods, including penetration testing and vulnerability scanning.
- Performance Testing: Proficiency in performance testing tools and techniques to identify and optimize performance bottlenecks.
- Test Automation: Proficiency with Atlassian Jira, Xray, JFrog Artifactory/Conan, Cucumber/Squish
Soft Skills:
- Regulatory: Knowledge of 21 CFR 820.30, ISO13485, IEC62304; EN ISO 14971:2012; safety by design; risk management structure desirable.
- Leadership: Ability to lead and mentor junior QA engineers.
- Continuous Learning: A passion for learning new technologies and staying up-to-date with industry trends.
Job Type: Full-time
Pay: $100,000.00 - $140,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
