V&V Engineer I (R&D)

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 Instrument Verification and Validation Engineer I.

Instrument Verification and Validation Engineer I, 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 is full-time onsite in Rochester, NY.

The Responsibilities

• 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.
• Design 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:

• Bachelors Systems Engineering, Mechanical Engineering, Electrical Engineering or equivalent.
• Experience working in a lab setting
• 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.
• Ability to travel up to 5%
• This position is not currently eligible for visa sponsorship.

Preferred:

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

The Key Working Relationships

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. Up to 60% of the time working within the lab running tests.

Physical Demands

Physical demands are the level and duration of physical exertion needed to perform critical tasks, such as: sitting, standing, walking, lifting, carrying, reaching, pushing, and pulling. Other physical demands include: 

• Bending 
• Vision 
• Crouching 
• Talking or hearing 
• Smelling 

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 $25/hour to $35/hour. 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 [email protected].