Staff Systems Engineer, 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.

QuidelOrtho is seeking a Staff System Engineer. The Staff Systems Engineer is often involved in high-level planning, integration, and optimization of complex systems. This role requires advanced problem-solving skills, the ability to lead a smaller team on large-scale projects, and a commitment to ongoing professional development. Additional responsibilities may include management of large technical projects or processes that span outside the immediate job area. Work is performed with limited oversight. Position may include the management of a team of 1-5 junior systems engineers.

This position will be onsite at our Rochester, NY office.

• Gather, analyze, and manage system requirements, ensuring alignment with regulatory standards and customer needs

• Conduct risk analysis and mitigation strategies, including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA)

• Develops a plan of execution using his/her knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project. Responsible for making moderate to significant improvements of processes, systems or products to enhance performance of technical job area

• Develop and execute system level test plans and protocols to validate system performance, reliability growth, and safety

• Diagnose and resolve system-level issues, ensuring timely delivery of solutions

• Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices

• Conduct statistical analysis to determine appropriate sample sizes for verification and validation activities, ensuring robust and reliable results

Required

• Requires minimum of 7 years of experience with BS in Systems Engineering, Biomedical Engineering or other engineering field with strong cross-discipline experience, 5 years' experience with MS or a PH. D, or equivalent combination of education and experience. Systems thinking acuity.

• Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement

• Demonstrated experience in applying statistical techniques to real-world problems, particularly in the medical device industry.

• Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.)

• Demonstrated experience in systems engineering tools and methodologies, as well as experience with software development, hardware design, reliability growth testing and systems integration.

• Strong verbal and written communication skills, with the ability to convey complex technical information to diverse audiences.

• Ability to work effectively in a collaborative, cross-functional team environment. Including the mentoring of more junior engineers.

• Strong analytical and problem-solving skills, with a focus on delivering innovative solutions.

Preferred

• Experience working with in-vitro diagnostic systems

• Experience with technical leadership of cross-functional development teams, functional management of 1-5 junior engineers.

Internal Partners:

Quality/Regulatory, Operations, Marketing, Manufacturing, Service, Valuemetric, Clinical Medical Affairs, Project Management Office

External Partners:

Development and Manufacturing partners, Customers, Manufacturing

The work environment characteristics are representative of an office, manufacturing, and laboratory environment. Flexible work hours to meet project deadlines.

Typically, 40% of time in meetings; 60% of time at the desk on computer/doing paperwork/ on phone, doing analytical work. Walking, 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.

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. The salary range for this position is $110,000 to $186,000. 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.

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 their 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.

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