Design Verification Engineer

Are you interested in working with the World s leading AI-powered Quality Engineering Company? Ready to advance your career, team up with global thought leaders across industries and make a difference every day? Join us at Qualitest!

We are looking for a Design Verification Engineer to join our growing team in Hercules, CA United States!

Position Overview:
The role primarily focuses on sustaining projects within the clinical diagnostics division, including diabetes instruments. The candidate will be actively involved in both hardware (HW) and software (SW) verification and validation testing.

Key Responsibilities:

• Support test execution, including dry runs and exploratory testing.
• Identify, document, and investigate bugs; create deviation and anomaly reports.
• Develop and maintain test cases and protocols for both HW and SW testing.
• Learn and provide training on instruments and associated software.
• Occasionally handle blood-based reagents and samples; support for chemistry (blood-based) tests.
• Other responsibilities - as required.

Required Qualifications:

• Proficient in test traceability and mapping HW/SW requirements and/or customer requirements to ensure comprehensive test coverage.
• Knowledgeable in:
  
  • 21 CFR Part 820 (Quality System Regulation)
  • IEC 62304 (Software Lifecycle and Development for Medical Devices)
  • IEC 61010 / IEC 60601 (Safety and Performance of Medical Electrical Equipment)
  • GLP, GDP, and electronic records compliance per 21 CFR Part 11.
  • EU-MDR knowledge is a plus.
• Skilled in HW and SW testing techniques, including but not limited to white-box and black-box testing, with a strong focus on early bug detection.
• Innovate / design new test methods or techniques, whenever required.
• Experience with ALM tools, regulated QMS tools, test execution, and bug tracking applications.
• Familiar with programming languages (ex. Python, JAVA, C++), and statistical tools like MATLAB and Minitab.

Preferred Qualifications:

• Strong time management and organizational skills.
• Ability to manage complex projects and deliver on time.
• Preferred educational background in Chemical, Biomedical, Electrical, or IT Engineering.

Must Have:

• Medical Device VnV (manual)
• ISO 13485/ISO14971/IEC62304
• Sustenance Design Changes

Nice to have:

• Python