Staff Software V&V Engineer

2 weeks ago

Irvine, United States DIALITY INC Full time $140,000 - $160,000
Job DescriptionJob 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

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