Staff Systems Engineer, R&D: Hardware/Software Integration

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

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.