Staff Systems Engineer

QuidelOrtho • Rochester, NY

1d • $125,000 - $135,000 • Onsite

About The Position

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 our next Staff Systems Engineer for in vitro diagnostic instrument development who will provide technical leadership and contribution to product design for QuidelOrtho’s instrument platforms. Our Staff System Engineers have extensive experience and expertise in the field of systems engineering. 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 is onsite full-time in Rochester, NY. Note: This position is not currently eligible for visa sponsorship.

Requirements

• Bachelor’s Degree in System Engineering, Biomedical Engineering, or related engineering field with strong cross-discipline experience is required, master’s degree preferred.
• Minimum 8+ years relevant experience required with a track record of delivering products in the medical, automotive, and/or defense industries, preferably with relevant medical device design exposure.
• Demonstrated experience using Six Sigma tools and techniques for process optimization and quality improvement
• Demonstrated experience in applying statistical techniques to real-world problems, particularly in the medical device industry.
• 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 in 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 10% both domestic and international.

Nice To Haves

• 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 Clinical Chemistry and/or Immunohematology in vitro diagnostic instruments.

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 development by creating a plan of execution using 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.
• 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.
• 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 our customer experience, product performance and safety.
• Perform other work-related duties as assigned.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level