Systems Engineer

Role Overview

Quidel Ortho, a world‑leading in vitro diagnostics company, is looking for a Staff Systems Engineer to support new product development. The successful candidate will provide technical leadership and contribute to product design for Quidel Ortho’s instrument platforms, leading small teams on large‑scale projects and managing technical projects that span multiple areas of the organization. This position is onsite 4 days a week with one day remote 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 development by creating a plan of execution using knowledge and ability to derive unique solutions and approaches that are cost‑effective and contribute to project success.
• 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.
• Provide status updates to senior leadership, highlighting progress, risks, and mitigation plans.
• Make moderate to significant improvements of processes, systems or products to enhance technical job area performance.
• Apply Six Sigma methodologies to identify, analyze, and improve processes within the development and manufacturing of medical devices.
• Develop and execute system‑level test plans and protocols to validate system performance, reliability growth, and safety.
• Conduct statistical analysis to determine appropriate sample sizes for verification and validation activities, ensuring robust and reliable results.
• 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.

• Bachelor’s Degree in Systems Engineering, Biomedical Engineering, or a related field (master’s degree preferred).
• Minimum 8+ years of relevant experience with a track record of delivering products in the medical, automotive, and/or defense industries, preferably with medical device design exposure.
• Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement.
• Demonstrated experience applying statistical techniques to real‑world problems, particularly in the medical device industry.
• 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, focusing on delivering innovative solutions.
• Customer focus to ensure the product experience meets expectations.
• Results orientation: capable of making commitments, setting priorities, and delivering results on time and on budget in a highly regulated environment.
• Situational adaptability: anticipates future concerns and builds effective cross‑functional relationships.
• Willingness to travel 10% domestically and internationally.
• This position is not currently eligible for visa sponsorship.
• Preferred:
  Familiarity with medical device regulations and standards (e.g., FDA, ISO
  13485).
• Preferred:
  Experience working with external development partners on complex solutions.
• Preferred:
  Familiarity with Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments.

• Internal Partners: R&D Leadership, Quality, Regulatory, Service, Manufacturing, Marketing, Project Management.
• External Partners:
  Clinical chemistry and transfusion medicine personnel (current and potential…