Qualitest
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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 (e.g. 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 / ISO 14971 / IEC 62304
Sustenance Design Changes
Nice to Have
Python
Benefits
Be a part of a company that strives to support diversity and inclusion in the workplace – we are one, we are many at Qualitest.
Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
We have more than 40% women and around 120 different nationalities.
Local and global opportunities – we offer you internal rotation and international mobility opportunities.
Clear view of your career and progression with the company – Qualitest is growing massively and giving you the opportunity to grow with us.
Work hard and play harder with our flexible and casual culture.
Enjoy employee events, amenities, and games.
Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions.
Enroll in competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
Stay active and get rewarded with our Corporate Wellness Program. We pay your gym membership and provide opportunities to earn additional vacation time for attendance.
Earn bonuses via our Client Referral and Employee Referral Programs.
Earn bonuses and spot awards by celebrating you and your peers’ achievements via Qudos.
Access Qualitest Employee Perks for discounts on travel, electronics, and more.
A competitive pay; salary range $90,000–$110,000.
Location Hercules, CA, United States
Employment Type Full‑time
Seniority Level Mid‑Senior level
Visit our website: https://www.qualitestgroup.com/
If you like what you have read, send us your resume and let’s start talking!
#J-18808-Ljbffr
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 (e.g. 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 / ISO 14971 / IEC 62304
Sustenance Design Changes
Nice to Have
Python
Benefits
Be a part of a company that strives to support diversity and inclusion in the workplace – we are one, we are many at Qualitest.
Celebrate culture, share knowledge with engineers from around the globe, and inspire each other through our differences.
We have more than 40% women and around 120 different nationalities.
Local and global opportunities – we offer you internal rotation and international mobility opportunities.
Clear view of your career and progression with the company – Qualitest is growing massively and giving you the opportunity to grow with us.
Work hard and play harder with our flexible and casual culture.
Enjoy employee events, amenities, and games.
Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions.
Enroll in competitive healthcare benefits. Qualitest will match towards your HSA if you choose to participate.
Never stop experimenting and learning with QCraft – our Learning & Development platform: 50,000+ courses, 300+ virtual labs, mentorship and leadership programs, professional tribes, sponsored certifications, and much more.
Stay active and get rewarded with our Corporate Wellness Program. We pay your gym membership and provide opportunities to earn additional vacation time for attendance.
Earn bonuses via our Client Referral and Employee Referral Programs.
Earn bonuses and spot awards by celebrating you and your peers’ achievements via Qudos.
Access Qualitest Employee Perks for discounts on travel, electronics, and more.
A competitive pay; salary range $90,000–$110,000.
Location Hercules, CA, United States
Employment Type Full‑time
Seniority Level Mid‑Senior level
Visit our website: https://www.qualitestgroup.com/
If you like what you have read, send us your resume and let’s start talking!
#J-18808-Ljbffr