Staff Software Reliability and V&V Engineer (Lead)
QuidelOrthoCity of Rochester, New York, United States
Posted July 16, 2025
120000 - 140000 USD year
Full Time
About the Company
> Bringing precision and passion in everything we do QuidelOrtho stands at the forefront of testing, tracking and disease analysis of health conditions ranging from HIV and hepatitis C to flu, strep and COVID-19. For decades, our precision and accuracy have guided clinicians and lab technicians in the moments that matter most. > Continuing our legacy in diagnostics Our portfolio serves the entire healthcare continuum: from high-volume, high-complexity hospitals and labs to point-of-care, retail and over-the-counter markets. This enables us to continue our legacy of diagnostics in an ever-changing environment where we're passionately pursuing the unknown to advance diagnostic science and care. > Raising the bar in diagnostic care Ranked among the world’s largest in vitro diagnostics (IVD) providers, we’re building on more than 120 years of collective experience and innovation. We combine industry-leading expertise in immunoassay and molecular testing with a global footprint in point-of-care settings, clinical labs and transfusion medicine to advance critical diagnostic solutions at scale. > Powering a healthier future for all Inspired by a spirit of service, QuidelOrtho is committed to enhancing the wellbeing of people worldwide and happy in the knowledge we are making a difference. To contact us, please visit https://www.quidelortho.com/global/en/contact-us. For career opportunities, please visit: https://careers.quidelortho.com/global/en. #QuidelOrtho #BetterTogether #PowerUpLabs #HealthierFuture #DiagnosticFrontier #AdvancingScience #TalentNetwork
Job Description
QuidelOrtho is seeking a Staff Software Reliability and V&V Engineer (Lead) to lead and be part of an engineering team responsible for formal verification and validation of complex medical devices under FDA regulations. The role involves managing teams, overseeing reliability and V&V planning, and ensuring regulatory compliance.
Requirements
- B.S. or M.S. Degree in Computer Science, Chemistry, Biochemistry, Biology, Engineering, or a related discipline
- 15+ years of experience, preferably 10 years leading a large team in a medical device environment
- Excellent problem-solving and troubleshooting skills, attention to detail, and V&V skills
- Strong knowledge of software configuration management tools, defect tracking tools, and peer review
- Understanding of IEC 62304, ISO 13485, ISO / EN ISO 14971, and FDA QSR experience or equivalent FDA software development requirements
- Strong organizational and communication skills, people management skills, and ability to manage multiple projects
- Experience in product development and experimental design
- Ability to work within cross-functional teams
- Knowledge of Application life cycle management (Agile method preferred)
- Ability to participate in planning and managing projects
Benefits
- Comprehensive benefits package including medical, dental, vision, life, and disability insurance
- 401(k) plan
- Employee assistance program
- Employee Stock Purchase Plan
- Paid time off (including sick time)
- Paid Holidays
