Staff Systems Engineer, Medical Diagnostics Product Development

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