Instrument Verification and Validation Engineer
QuidelOrthoHighlight
Summary
About the Role
About You
- Bachelor's or master’s degree in computer science, Mechanical Engineering, Electrical Engineering, System Engineering or any other related fields.
- 1 to 5 years of experience, preferably in a pharmaceutical or medical device environment.
- Understanding of IEC 62304 or equivalent FDA software development requirements.
- Good analytical and problem-solving skills.
- Good organizational skills and ability to manage multiple tasks.
- Experience in product development and experimental design.
- Ability to work within cross functional teams.
- Strong communication skills, written and verbal.
- Working knowledge of relevant analytical tools.
- Ability to participate in planning and managing projects.
- Working knowledge of product development tools and processes.
- Knowledge of related quality systems regulations and processes.
- Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software).
- Some knowledge of basic Programming, Scripting, setting up an Automation Environment and Test Automation development.
- Knowledge of Application life cycle management (Agile method preferred).
- Ability to write test plans, test cases and test reports.
- Ability to travel up to 5%.
- Instrument V&V Theory & Application.
- ISO 13485, ISO / EN ISO 14971 and FDA QSR experience.
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) and paid Holidays.
- Bonus eligible.
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