Job Description

Job Description

Diality Inc, a privately held medical device company located in Irvine, CA is committed to improving the quality of life for patients with kidney disease. We are developing a smart, flexible, portable hemodialysis machine that will enable patients to self-treat at home or wherever they travel. The extremely versatile hemodialysis solution will allow more patients to benefit from their true dialysis prescription at home or in a variety of care settings, including nursing homes, hospitals, and dialysis centers, without the need for pre-mixed dialysate bags or external water-treatment systems.

The Staff Software Test Engineer will play a pivotal role in leading the software test development of critical software for our medical devices, ensuring software quality.

**Duties & Responsibilities: **

• Manage the complete project(s) from start to finish with minimal guidance; define project milestones and delivery, coordinate with team members to manage project tasks and track progress/result to align with project deadlines.
• Collaborate with cross-functional teams to resolve any challenges and provide solutions to the problems.
• Re-define and implement test framework architecture changes as needed to support project needs.
• Review and understand the software requirements, collaborate with cross-functional team to ensure requirements are accurate, concise and complete.
• Define and communicate test strategy to verify software requirements; provide innovative test methods to ensure complete test coverage.
• Manage software test activities: Create test plan, provide test estimates, develop test protocols, automate test cases, execute test cases, create test metrics and reports.
• Track software defects, collect data and perform dry run as needed to assist cross-functional team to debug system problems, conduct bug verifications.
• Understand existing test framework architecture; bring in new ideas to improve the test framework design and continuously expand its functionality with minimal guidance.
• Utilize available materials and determine the right course of action to resolve a variety of problems with minimal support.
• Lead and mentor junior engineers, fostering a collaborative and high-performing software test team.
• Perform code review and ensure code design, code quality and maintainability.

**Qualifications & Requirements: **

• Master’s degree in Computer Science, Software Engineering, or a related field (or Bachelor's degree with extensive experience).
• At least 10-15 years of experience in software testing in the medical field or other regulated industries.
• Strong development experience in Python Automation Framework, e.g. Pytest, Openpyxl, Jinja, Click, Pandas, Tkinter, etc.
• Effective utilization of Python objects.
• Proven in-depth knowledge of Software/Test development lifecycle methodologies, principles and practices.
• Requires critical thinking to understand advanced issues and implications.
• Superior analytical and problem-solving skills with a track record of delivering high-quality solutions.
• Strong proficiency in Python for scripting, automation, and data analysis tasks.
• Demonstrated experience with IEC 62304 medical device software lifecycle standards.
• Exceptional communication, collaboration, and leadership skills with the ability to mentor and inspire others.
• Demonstrate flexibility to adapt to new directions and task priority changes.
• Demonstrate ability to lead team discussions and willingness to comply with team decisions.
• Familiar with working in Windows and Linux environments.
• Familiar with Git, Jira and Jama.
• Familiar with PyCharm IDE.

Physical Demands:

• Sustained periods of time standing and sitting in a laboratory
• Sitting at a desk utilizing a computer
• Some lifting of<25 pounds

Working Environment :

Typical office areas with offices, cubicles and conference rooms. Typical laboratory and chemical storage areas which may contain hazardous compounds requiring adherence to safe handling practices.

Travel:

Willingness to travel domestically as needed (up to 10%) primarily to visit vendors and attendance at select conferences.