The Opportunity

 

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Senior Instrument Verification and Validation Engineer.

Senior Instrument Verification and Validation Engineer, provides support for new products, assay / instrumentation integration, technology transfer and other instrument V & V activities. perform hardware verification and validation testing, independently and/or, on multi-disciplined teams throughout the equipment/instrument development life cycle process. Apply system engineering methods for design and analysis, design verification, subsystem validation, and post launch product support.

This position will be onsite full-time in Rochester, NY

The Position

Actively participates on design teams, understands project goals and timelines, and provides leadership to ensure product launch success.Work independently and as a team member to plan, write, and execute test cases according to QuidelOrtho Quality Management System, FDA regulations, and ISO standards.Actively communicates project status, challenges, concerns and resource constraints to area managementDesign new test procedures for new features and functionality.Develop self and always maintain knowledge in hardware test engineering field.Participate in the execution, analysis, and reporting of subsystem and system testing.Willingness to work in FDA/EU regulated medical devices environment utilizing defined processes and best practices.Develop and execute verification and validation activities.Execute test procedures, record, and later follow-up anomalies found during testing.Communicate Test development and Execution status to Team Leader.Perform other work-related duties as assigned.

The Individual

Required:

Education: Bachelor’s degree or higher in Systems Engineering, Mechanical Engineering, Electrical Engineering or equivalent. Background/Degree in Science or Engineering.Minimum of 10 years of experience supporting verification and validation testing.Ability to carry out general biochemical laboratory procedures including handling of human blood/serum samples and reagents for testing purposes, on laboratory equipment.Excellent documentation skills for: maintaining technical design inputs/outputs, test planning, test case design, execution, and requirements traceability, and reviewing the work quality of others – with great attention to detail.Experience with verification and validation testing for medical devices. Flexibility – the ability to switch between projects at a moments’ notice, due to shifts in ever-changing priorities.Excellent problem-solving and trouble-shooting skills, requires some initiative and judgment.Test Automation, Computer Systems - Setup configurations, installations, automation, Cybersecurity.Instrument Engineering Theory & ApplicationBasic programming skills (e.g. VBA and/or a variant of C, python, etc.)Ability to travel up to 25%This position is not currently eligible for visa sponsorship. 

Preferred:

Experience with Jira, Windchill and Quality CenterExperience with any analyzers - especially family of Vitros® Systems is a plus.Knowledge of development environment tools like Serena Business Mashups, HP (ALM) Quality Center, Aligned Elements, and Microsoft Team Foundation Server a plus.

The Key Stakeholders

Internal Partners:

Sustaining Engineering, Electrical Engineering, Systems Engineering, PMO, Triage Team, QA, RA

External Partners:

Vendors and customers

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. May have to preform testing in environmental chamber or work in cold rooms.

Physical Demands

Walking, bending, smelling, standing, and sitting for long periods of time are routine to accomplish tasks in this role.  Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Ability to work in environmental chamber and/or cold rooms.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $90,000 to $105,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.