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 Systems Engineer I. This individual will assist in conducting technically challenging systems-type investigations to address on-market product quality issues and recommend solutions.

Collaborating cross-functionally across Ortho, and with customers, they will use data analytics to drive scoping of investigations and decision making. They will use technical knowledge of electro/mechanical/software systems and scientific principles of how assays work to design, conduct and document experiments to systematically identify failure mode/s and establish root cause/s. This position is located in Rochester, NY. A hybrid work schedule may also be considered.

The Responsibilities

• Assess failure modes of potential quality issues of systems nature related to hardware/software, reagents, samples, testing protocol and consumables reported by customers and internal stakeholders.
• Perform investigation into the product issue/s to understand nature of the problem.
• Work with cross-functional representatives in quality, customer support, lifecycle management team, operations and our development partners, to define the problem and deviation from intended performance.
• Collect and analyze data from instruments and databases. Use knowledge of data analytics and statistics to discern significant trends to assess contribution of potential root causes.
• Assist in designing and conducting experiments to determine root cause for small-scale investigations, or as part of a team to support large-scale investigations.
• Propose corrective actions for implementation to fix product issues.
• Document and maintain investigation records and findings.
• Communicate investigative findings to the Customer Service Organization in a way that enables broad dissemination and actionable use of technical knowledge.
• Complete Quality System records in conjunction with product investigations.
• Operate equipment in a biohazard lab environment.
• Communicate with an international community of technical support staff.
• Seek technical information and engender collaboration from development partners, inside/outside Ortho and outside the US.
• Learn the operating principles and detailed engineering features of complex electro/mechanical/software systems and scientific principles of how assay work.
• Occasional travel.

• Makes hiring recommendations, trains employees, plans work of others, and reviews work quality and quantity of others.

• Performs other work-related duties as assigned.

The Individual

Required Skills

• 1-3 progressive years of experience with a Bachelor's degree in Engineering or related scientific discipline. Systems, Mechanical, Electrical, Chemical or Biomedical Engineering preferred and/or equivalent combination of education and experience.
• Systems thinking acuity and a keen interest in diving deep into complex product issues and learning different technologies.
• Demonstrated ability in technical analysis and evaluation of data required.
• Ability to have a customer-oriented mindset to better anticipate needs, resolve issues more quickly and ultimately create a better user experience.
• Ability to work well in a team environment.
• Excellent organizational skills.
• Excellent communication, influencing and conflict resolution skills.
• Experience with technical writing and English fluency.
• Ability to adapt quickly to obstacles and changing demands.

Preferred Skills:

• Experience with clinical chemistry and/or immunohematology systems.
• Experience in application of design of experiments to an industry setting.
• Six Sigma and/or Kepner-Tregoe background.
• Background in applied statistics.
• Experience with MATLAB and/or other programming/scripting languages.

Key Working Relationships:

Internal: Field Triage Team (of which this job is part), Development Team (for translating proposed solutions into actual designs), Quality (for compliance process), Operations (for deep subject matter expertise of manufacturing processes), Ortho Care (for seeking additional information, and for communicating findings).

External: Development Partners and Suppliers (for deep investigational and raw materials assistance, and for translating proposed solutions into CAPA), Customers (for additional information related to investigations).

The Work Environment

This position operates primarily in a typical office environment. Approximately 25% of time will be spent in a laboratory environment which may include include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. This position requires occasional travel between 5-10% of your time.

Salary Transparency

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, its is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on that facts and circumstances of each case. A salary range for this position is $49,000 to $88,000. 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