Qualitest · 4 weeks ago
Design Verification Engineer
Hercules, CA
Full-time
Hybrid
Entry, Mid Level
$90K/yr - $110K/yrQualitest is a leading AI-powered Quality Engineering Company, seeking a Design Verification Engineer to join their team. The role focuses on sustaining projects within the clinical diagnostics division, involving both hardware and software verification and validation testing.
ConsultingEnterprise SoftwareInformation ServicesInformation TechnologyOutsourcingQuality AssuranceSoftwareTest and Measurement
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
Qualification
Required
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
Medical Device VnV (manual)
ISO 13485/ISO14971/IEC62304
Sustenance Design Changes
Preferred
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
Benefits
401k plan where Qualitest will match your contributions accelerating your savings plan.
Enrollment into one of our competitive healthcare benefits.
Qualitest will match towards your HSA if you choose to participate.
QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
Corporate Wellness Program. We pay your Gym membership and giving you opportunities to Earn additional vacation times for attendance the gym!
Bonuses via our Client Referral and Employee Referral Program’s.
Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
Qualitest Employee Perks for discounts on anything from travel to electronics.
Company
Qualitest
Qualitest is the world’s leading managed services provider of AI-led quality engineering solutions.
Founded in 1997
5001-10000 employees
H1B Sponsorship
Qualitest has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (36)
Funding
Current Stage
Late StageTotal Funding
unknown2019-07-10Acquired
Leadership Team
Andrew Duncan
Chief Executive Officer
Lihi Segev
Executive Vice President
Recent News
2025-07-14
Company data provided by crunchbase