Hiring: Staff Systems Engineer, Medical Diagnostics Product Development Company: QuidelOrtho Location: Rochester, NY Job Posted Time: 2026-09-03 10:33:21 Employment Type: Full-time Target Skills & Keywords : Linux, R About the job Experience: •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. Required Skills: •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 •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. Qualifications: •Operational 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. •Operational 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 •Operational familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments. •Project Management Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!