Design Verification Engineer

Are you interested in working with the World’s leading AI-first 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 QualityAI!

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.

Minimum 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 Skills:

• 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 n automation).
• ISO 13485/ISO14971/IEC62304.
• Sustenance Design Changes.

Nice to have:

• Python and automation background.

Benefits:

Why QualityAI?
QualityAI is an AI-first quality engineering company helping enterprises deploy and scale complex systems with greater confidence. Operating across data, models, platforms, infrastructure, and operational environments, the company provides assurance and engineering expertise that helps organizations ensure systems perform reliably in real-world conditions.

Formerly Qualitest, QualityAI supports global enterprises across regulated and technology-driven industries, combining deep engineering heritage with AI-enabled delivery, operational assurance, and lifecycle expertise to help clients achieve certainty at go-live.

• Be a part of a company who strives to support for diversity and inclusion in the workplace - we are one, we are many at QualityAI. Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
• Local and global opportunities - we offer you internal rotation and international mobility opportunities to grow your career.
• Clear view of your career and progression with the company - QualityAI is growing massively (since Jan 2021 - added more than 2000 engineers) and giving you the opportunity to grow with us.
• Work hard and play harder with our flexible and casual culture. Take a break from work and join an employee event, or enjoy the amenities and games provided from one of our Employees Centers.
• Never stop experimenting and learning with QualityAI Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs and much more.
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn - tap your network for net-worth.
• A Competitive pay, the salary range for the role is $90,000 - $110,000.

If you like what you have read, send us your resume and let’s start talking!
Intrigued to find more about us?
Visit our website at https://www.QualityAIgroup.com/
If you like what you have read, send us your resume and let’s start talking!
LinkedIn: https://www.linkedin.com/company/qualityaigroup