Reporting to the Lead Software Quality Engineer, this position is responsible for test case development and Python Scripting and execution in an FDA-regulated environment. The successful candidate will have advanced knowledge of software quality engineering, strong software testing skills including documentation and reporting. You will be validating Class III software applications which experience ongoing feature changes and require risk-based testing, generally on aggressive timelines. Your critical eye to conduct accurate technical reviews is essential for this role.
This position requires critical attention to detail, ability to work collaboratively with others, technical aptitude, problem-solving skills, and adaptability to the needs of multiple projects simultaneously. Daily accountability and written task tracking using a variety of software tools to different managers / clients is mandatory. Occasional onsite presence, respecting Pandemic social distancing guidelines, may be requested by our clients.
List of Responsibilities:
- Create Python scripts for test automation, including dry run and formal execution
- Complete Client training program on medical device(s). Be familiar with product documentation, version control and documentation repositories.
- Set up & test multiple software applications concurrently in a fast-paced environment
- Be an articulate and concise communicator with the ability to communicate across highly diverse, international teams to capture required information quickly. Absorb details from working sessions which may be held virtually. Take and log accurate notes from discussions. Video conferences with enabled webcams are preferred.
- Perform software validation on Class III software applications – including bug fix builds
- Review requirements and design documents for appropriate level of detail from which all test plans, protocols and test cases will evolve
- Create test cases & Python scripts, and test reports with appropriate detail / rigor for a regulated environment
- Support fellow testers by performing technical reviews of test protocols and providing ‘best practice’ test execution feedback where needed.
- Report and verify defects & help ensure requirements traceability.
- Represent SQE in Design Reviews and other early-stage technical meetings, working closely with software engineers, Project Management, and other stakeholders
- Early identification and communication of risks related to assigned projects
- Continually identify test coverage gaps and work with the appropriate team members to close them
- Escalate test and/or quality issues to the SQE Lead with appropriate urgency and level of detail
- Ability to complete the assigned tasks in a timely manner to meet project due dates
- Solid experience creating Python scripts for verification & validation of software applications in an FDA environment
- 8+ years’ experience in software quality engineering & testing in the medical device industry
- Experience writing test plans and test reports, and planning and writing effective test cases
- Solid understanding of and experience with different types of testing methods, such as functional, system, integration, User Interface (UI), usability, performance, negative scenario, and others as needed
- Extensive knowledge of FDA and ISO regulations and standards required
- Familiarity with defect tracking software and test management tools
Python: 5 years (Required)
Selenium: 2 years (Preferred)
Test automation: 5 years (Required)
Git usage in a Linux environment (Required)
Medical Device Testing: 5 years (Required)
Proven communication skills with development and operations/support teams (written/oral), especially in life sciences, medical device and highly technical environments
Must be highly motivated and have strong technical and analytical skills
Must be self-sufficient and able to work independently yet also handle direction well
Paid time off
Monday to Friday
All work is performed onsite
All covid protocols are followed – masks are worn onsite
Work Location: Irvine, CA