Design Verification Engineer at Qualitest Concord, CA

Qualitest; Concord (CA); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

401k match

Healthcare benefits

Career growth

Job summary

Qualitest seeks a Test Engineer for the clinical diagnostics division focusing on hardware and software verification and validation of diabetes instruments. You will contribute to test planning, execution, and defect reporting across HW and SW domains.

The role requires knowledge of medical device regulations and standards, experience with ALM/QMS tools, and programming in Python/Java/C++. Occasional handling of blood-based reagents may occur as part of testing.

Qualifications

• Experience mapping HW/SW requirements to test coverage.
• Knowledge of 21 CFR Part 820, IEC 62304, IEC 61010/60601, GLP/GDP/21 CFR Part 11.
• HW and SW testing techniques; early bug detection.
• Familiar with ALM tools, regulated QMS tools, test execution, and bug tracking.

Responsibilities

• Support test execution, including dry runs and exploratory testing.
• Identify, document, and investigate bugs; create deviation/anomaly reports.
• Develop and maintain test cases/protocols for HW and SW testing.
• Learn and train on instruments and associated software.
• Occasionally handle blood-based reagents; support chemistry tests.

Skills

Test traceability

Regulatory knowledge

HW/SW testing

Programming languages

Education

Biomedical/Electrical/IT Engineering

Tools

Python

Java

C++

MATLAB

Job description

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

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 to grow your career.
• Clear view of your career and progression with the company – Qualitest is growing massively (since 2021 – tripled our employees base – we now have more than 8,000 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, enjoy the amenities and games provided from one of our employee centers. Save your earnings and prepare for your future by enrolling in our 401k plan where Qualitest will match your contributions accelerating your savings plan.
• Take care of health with enrollment into one of our 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 give you opportunities to earn additional vacation times for attending the gym!
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
• We recognize our employees work via our Qudos platform - You can earn bonuses and spot awards by celebrating your and your peers’ achievements.
• Planning a vacation? Looking for car insurance? Get access to Qualitest Employee Perks for discounts on anything from travel to electronics. With so many offerings the savings are endless!
• A competitive pay, the salary range for the role is $90,000 - $110,000.