V&V Engineer I (R&D)
V&V Engineer I (R&D)
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Job Description
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 6000 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 arethe level and duration of physical exertion needed to perform critical tasks such as:sitting standing walking lifting carrying reaching pushing and 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 .
Employment Type
Full-Time
