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About the Role

QuidelOrtho is seeking a Staff Systems Engineer to support R&D. This role requires expertise in systems engineering and hardware/software integration, with in-depth knowledge of systems engineering principles, processes, and tools. The position involves high-level planning, integration, and optimization of complex systems, advanced problem-solving, leading teams on large-scale projects, and a commitment to professional development. Additional responsibilities may include managing large technical projects or processes that span outside the immediate job area, with work performed under limited oversight.

Responsibilities

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).
Lead formal design reviews; provide system-level perspective and ensure compliance with design controls.
Drive instrument and laboratory automation development by creating a plan of execution using unique solutions and approaches that are cost-effective.
Utilize modeling, simulation, and data analytics to assess system behavior and optimize design performance.
Diagnose and resolve system-level issues, ensuring timely delivery of solutions.
Use system engineering tools to carry out Root Cause Investigations and determine corrective and preventative action plans.
Lead R&D activities associated with Field Corrective Actions, Product Obsolescence, and Current Product Improvement.
Provide status updates to senior leadership, highlighting progress, risks, and mitigation plans.
Make moderate to significant improvements of processes, systems, or products to enhance performance.
Develop and execute system-level test plans and protocols to validate system performance, reliability growth, and safety.
Collaborate with key stakeholders and external design partners to deliver product features that improve customer experience, product performance, and safety.
Perform other work-related duties as assigned.

Requirements

Bachelor’s degree in systems engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience of hardware/software development required; master’s degree preferred.
Minimum 7+ years of relevant experience with a track record of delivering products in a regulated environment (medical, automotive, aerospace, defense).
Experience with laboratory or manufacturing automation systems, including hardware and software development and integration.
Experience with the integration of multiple software applications across multiple platforms running Linux and Windows operating systems.
Demonstrated experience in systems engineering tools and methodologies, 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 mentoring junior engineers.
Strong analytical and problem-solving skills, with a focus on delivering innovative solutions.
Strong customer focus to ensure product experience is consistent with expectations.
Results orientation: capable of making commitments, setting priorities, and delivering results on time and on budget in a highly regulated environment.
Situational Adaptability: ability to see ahead clearly and anticipate future concerns.
Ability to develop and maintain effective cross-functional relationships and earn trust and respect.
Ability to travel up to 5% both domestically and internationally.
Familiarity with medical device regulations and standards (e.g., FDA, ISO 13485, etc.).
Demonstrated experience in successfully working with external development partners in delivering complex solutions.
Familiarity with AI-based software development and system modeling techniques.
Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments.
Experience with Laboratory Automation systems and Clinical-Chemistry/Immuno-Assay analyzers.
Experience with Laboratory Automation Middleware Applications or similar software.

Skills

Systems Engineering
Hardware/Software Integration
Risk Analysis
FMEA
FTA
Design Reviews
Modeling
Simulation
Data Analytics
Root Cause Investigation
Corrective and Preventative Action Plans
System Level Test Plans
Cross-functional Collaboration
Mentoring
Analytical Skills
Problem-Solving
Customer Focus
Results Orientation
Situational Adaptability
Communication Skills

Location

Rochester, NY

Work Type

Onsite
Full-time

Experience Level

7+ years relevant experience
Staff level

Education Level

Bachelor’s degree in systems engineering, Biomedical Engineering, or related engineering field
Master’s degree preferred

Salary/Compensations

$100,000 to $130,000
Bonus eligible

Benefits

Medical insurance
Dental insurance
Vision insurance
Life insurance
Disability insurance
401(k) plan
Employee assistance program
Employee Stock Purchase Plan
Paid time off (including sick time)
Paid Holidays

About the Company

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.

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.