Validation Lead - Clinical Diagnostics

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 Validation Lead - Clinical Diagnostics to join our growing team in Concord, California!

Role - Validation Lead - Clinical Diagnostics

Location - Concord, CA (on-site)

As a Senior Validation Engineer within  Global Systems Engineering Organization, you’ll be right at the forefront of Clinical Diagnostics R&D Group – leading the design validation of clinical diagnostics products across immunology, immunohematology, diabetes, infectious diseases and women’s reproductive health applications. 

You will leverage your clinical domain experience, quality mindset and analytical skills to own design validation deliverables such as plans, protocols, test execution, issues investigations and results reports for assigned projects.

You will assess products conformity to user needs, intended use and use environments and support new products launch decision with clear and traceable objective evidence.

You will bring customer centricity to development teams, influence them to integrate our user’s perspective in their design and testing, help them to focus on delivering a best-in-class experience and quality for our customers.

You will bring multi-disciplinary teams of clinical, human factors, R&D, marking and sales specialists together to face users and gather their feedback on design artifacts with various maturity.

How You’ll Make an Impact:

· Leverage extensive clinical laboratory domain experience and strong relationships to adequately represent Bio-Rad products users’ perspectives. Train design teams to have a deeper understanding of clinical practices and set up representative use environments, laboratory workflows and routine practices. Champion the adopt on and execution of customer centricity principles.

· Lead the planning, design, coordination and execution of design validation studies in collaboration with clinical affairs, human factors, R&D, marketing and sales specialists to gather user feedback at various stages of product design.

· Manage external vendors or test labs involved in validation testing as needed, execute well coordinated internal and external testing. 

· Generate traceable and comprehensive objective evidence and documentation for design validation including plans, protocols, issues and reports supporting regulatory submissions strategies.

· Analyze test results, identify and resolve complex user related and technical issues, identify areas for improvement and guide the product development team to prioritize feedback and improvements.

· Leverage a global organization talent pool to optimize design validation testing activities quality, cost & duration. Drive risk-based validation approaches, ensuring alignment with product risk classification and intended use environments.

· Communicate technical information clearly and concisely to both technical and non-technical audiences.

What You Bring:

Education: MSc or Ph.D in Biomedical Engineering, Medical Biology or equivalent. 

Work Experience:

· 8+ years’ experience in Design Validation for new In vitro diagnostics (IVD) or medical device (MD) products. Demonstrated a leading role in planning, execution and reporting of design control validation studies in R&D, clinical and human factors context.

· 3+ years’ functional or project management experience. Successful track record of bringing together and focus diverse teams, including customers, to lunch quality products.

· 2+ years’ hands on work in a clinical diagnostics or hospital environment. Successful track record of establishing and maintaining relationships with our customers.

· Excellent listening, communication, and social skills with a user / customer centric mindset. Field experience is desirable.

· Excellent observation, analytical, and critical thinking skills with data science fluency. Proficiency with Python, or Matlab preferred.

· Ability to work and excel within a global, fast paced, and cross-functional work environment with a continuous learning mindset.

· LEAN Green Belt or Black Belt certification is desirable.

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.
• 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 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 Qualitest Tech academy: 3000+ training courses, mentorship programs, technical tribes, sponsored certifications, leadership programs 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!
• Salary of $100-105k anually.
• Earn bonuses via our Client Referral and Employee Referral Program’s. Refer and earn – tap your network for net-worth.
• 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!

Intrigued to find more about us?

• Visit our website at Careers - Qualitest Group

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