Senior VnV 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 Senior VnV Engineer to join our growing team in Hercules, CA United States!

As a Test Engineer within our Global Systems Engineering Organization, you’ll be right at the forefront of Bio-Rad's Clinical Diagnostics R&D Group – heavily involved in System Design Integration/Verification of new clinical diagnostics products across molecular diagnostics, clinical immunology, and immunohematology platforms. Reporting to the Verification Lead, your key activities will include test methods development/validation, performing dry runs, test execution, test results analysis and reporting. You will leverage your knowledge of engineering principles and implement systems engineering practices (requirements, architecture) on new product development projects. With a successful track record for complex systems development, you will produce technically relevant objective evidence to evaluate design quality throughout the entire product development lifecycle. Your technical curiosity and analytical skills will be essential to build effective relationships with technical design subject matter expert across multidisciplinary engineering & scientific teams. You will influence New Product Development to maintain the focus on delivering safe, effective and compliant product design to our customers. You'll also collaborate with multi-disciplinary teams of engineers and scientists, providing your technical knowledge and insights to ensure that the product architecture and design conform to the highest levels of quality, reliability, usability and functionality requirements.

What You Bring

• Bachelor's or Master's degree in Computer Science or Engineering, Software Engineering, Biomedical Engineering, or a related field.
• Familiarity with a diverse range of engineering test equipment/tools/methods is a must, with evidence in a solid track record for experimental hands on work.
• Foundation knowledge and experience with Integration/Verification testing is a must.
• Minimum 2-4 years of experience in system testing or software system testing. Test automation is an advantage.
• Strong understanding of System Architecture and Integration points.
• Ability to work independently and as part of cross-functional team.
• Strong experience in troubleshooting and managing configuration of medical devices under test.
• Knowledge of regulatory requirements and standards for medical devices, including FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and IEC 62304.
• Excellent communication skills and ability to work collaboratively in a multidisciplinary team environment.
• Strong analytical skills, attention to detail, and problem-solving abilities to identify and resolve software issues.
• Ability to thrive in a dynamic and regulated environment, with a focus on delivering high-quality software solutions for medical diagnostics.
• Someone with a lean mindset.
• Willing to travel to different test site/labs (e.g. For Environmental Testing).
• Working knowledge of laboratory safety and settings.
  
  

Must Have

• Minimum 2-4 years of experience in system testing or software system testing. Test automation is an advantage.
• Strong experience in troubleshooting and managing configuration of medical devices under test.
• Knowledge of regulatory requirements and standards for medical devices, including FDA regulations (e.g., 21 CFR Part 820), ISO 13485, and IEC 62304.
  
  

Preferred Qualifications

• Certification or training in quality assurance, software testing, or regulatory compliance related to medical devices (e.g., ISO 13485, IEC 62304).
• Previous experience in the medical device industry, particularly in the development of diagnostic software or related healthcare technologies.
• Familiarity with product development life cycle (PDLC) processes, agile methodologies, and continuous integration/continuous deployment (CI/CD) practices.
  
  

How You'll Make An Impact

• Develop, update, and execute comprehensive test cases, and test scripts to verify the functionality and performance of medical diagnostic device.
• Conduct rigorous testing activities, including system testing, system integration testing, chemistry related testing and regression testing.
• Develop/Setup and maintains various test fixtures.
• Collaborate closely with system engineers, scientists, and software developers to identify and troubleshoot and root cause analysis for product issues.
• Document and report anomalies, and test results clearly and concisely, adhering to regulatory guidelines and audit requirements.
• Participate in design reviews, and quality assurance processes throughout the software development life cycle (SDLC).
• Stay updated with industry trends, best practices, and regulatory changes in medical device.
• Should be flexible to working hours, as needed and willing to learn in a fast pace dynamic working environment.
  
  

Benefits

Why QualiTest?

• Be a part of a company who strives to support for 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, or enjoy the amenities and games provided from one of our Employees 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 giving you opportunities to Earn additional vacation times for attendance 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 $100,000 - $110,000.
• Intrigued to find more about us?
  
  

Visit our website at https://www.qualitestgroup.com/

If you like what you have read, send us your resume and let’s start talking!