Staff Systems Engineer, Medical Diagnostics Product Development

QuidelOrtho; City of Rochester (NY); On-site; USD 100,000 - 130,000; Full time

Job summary

QuidelOrtho in Rochester, NY is seeking a Staff Systems Engineer to provide expertise in systems engineering and hardware/software integration. The role involves high-level planning, leading project teams, and ensuring design controls across medical device projects.

The successful candidate will have 7+ years in regulated settings, experience with lab automation, Linux/Windows platforms, and strong communication. Travel up to 5% may be required; onsite work is expected.

Qualifications

• Seven or more years of experience in regulated environments (medical/defense/aerospace).
• Experience with lab or manufacturing automation hardware/software integration.
• Experience integrating software across multiple physical or virtual platforms (Linux/Windows).
• Strong written and verbal communication and mentoring abilities.
• Travel up to 5% domestically and internationally.

Responsibilities

• Gather, analyze and manage system requirements with regulatory alignment.
• Lead design reviews and ensure design controls compliance.
• Drive automation development and optimization across instruments and labs.
• Use modeling, simulation and data analytics to assess performance.
• Perform root cause investigations and action plans.
• Provide status updates to senior leadership.

Skills

Systems thinking

Hardware/Software integration

Cross-functional collaboration

Technical leadership

Communication

Education

Bachelor’s degree in system engineering or related field

Master’s degree preferred

Tools

Linux

Windows

System modeling tools

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 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

At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our mission as a Staff Systems Engineer supporting R&D. The Staff Systems Engineer will provide expertise in systems engineering and hardware / software integration. They possess in-depth knowledge of systems engineering principles, processes, tools, and are 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.

This position will be onsite full-time in Rochester, NY.

The 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 his/her knowledge and ability to derive unique solutions and approaches, which are cost effective and contribute to the success of the project.
• 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 the R&D activities associated with Field Corrective Actions, Product Obsolescence, and Current Product Improvement as determined by business needs.
• Provide status updates as needed to senior leadership, highlighting progress, risks, and mitigation plans.
• 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.
• Collaborate with key stakeholders and external design partners to deliver product features that improve our customer experience, product performance and safety.
• Perform other work-related duties as assigned.

The Individual

Required

• Bachelor’s degree in system engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience of hardware / software development is required, master’s degree preferred.
• Minimum 7+ years relevant experience required with a track record of delivering products in a regulated environment such as medical, automotive, aerospace, and/or defense industries. Preferably with relevant medical device design exposure.
• Experience with laboratory or manufacturing automation systems including the development and integration of hardware and software solutions for these systems.
• Experience with the integration of multiple software applications across multiple physical or virtual platforms running Linux and Windows operating systems.
• 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.
• Must have strong customer focus to ensure that the experience delivered by the product is consistent with expectations.
• Results orientation: Must be capable of making commitments, setting priorities, and delivering results on time and on budget in a highly regulated environment.
• Situational Adaptability: Sees ahead clearly; can anticipate future concerns.
• Develops and maintains effective cross functional relationships and is capable of quickly earning trust and respect.
• Must have the ability to travel up to 5% both domestic and international.

Preferred

• 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 modelling techniques. Including adaptive or genetic algorithms used to resolve resource utilization and routing problems in complex manufacturing or laboratory automation systems
• 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

The Key Working Relationships

Internal Partners

• R&D Leadership
• Marketing
• Design Quality
• Regulatory
• Service
• Information Technology
• Technical Publications
• Supply Chain/Operations
• Project Management

External Partners

• Various Laboratory Automation hardware and software partners in accordance with Business strategy
• Clinical chemistry and Transfusion medicine personnel (current and potential customers)

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work.

Travel requied. Travel includes airplane, automobile travel and overnight hotel. Frequent work in a BL-2 Lab environment will require wearing of approved and provided clothing and eye protection.

Physical Demands

No strenuous physical activity, though occasional light lifting of files, equipment, and related materials is required. 60% of time in meetings, working with team, or talking on the phone, 40% of time at the desk on computer, doing analytical work.

Occasional domestic and international travel required. Travel includes airplane, automobile travel and overnight hotel. Must have the ability to travel up to 5% both domestic and international.

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 $100,000 to $130,000 and is bonus eligible. 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.