Sr. Software Engineer

ABOUT IRIDEX

Iridex Corporation is a global medical technology company advancing the treatment of glaucoma and retinal diseases through innovative laser-based solutions. Since 1989, our technology has been used by ophthalmologists around the world to help preserve and improve vision.

We’re looking for an experienced, hands-on Senior Software Engineer to help design and develop the software and embedded systems behind our next generation of ophthalmic medical devices.

At Iridex, you’ll have the opportunity to work on meaningful technology that directly supports physicians and patients worldwide—while collaborating with a talented, cross-functional team in an environment that values innovation, ownership, teamwork, and continuous improvement.

THE OPPORTUNITY

The Senior Software Engineer is responsible for the design, development, integration, testing, and maintenance of software and embedded systems for complex Class II Medical Laser Systems.

This is a hands-on individual contributor role requiring strong software engineering skills and an understanding of electrical hardware and embedded systems. The Engineer will work closely with Electrical, Hardware, Systems, Manufacturing, Quality Assurance, Regulatory Affairs, and other cross-functional teams to develop new products, enhance existing products, troubleshoot system-level issues, and support products throughout their lifecycle.

The ideal candidate is a highly capable engineer who can work independently, solve complex technical problems, and contribute to software architecture, development, debugging, verification, and product integration in a regulated medical-device environment.

WHAT YOU'LL DO

• Design, develop, test, debug, and maintain software and embedded systems for medical laser products.
• Develop software for embedded controllers, system interfaces, diagnostics, manufacturing test systems, and engineering tools.
• Write clean, maintainable, well-documented code using C/C++, Python, or other appropriate programming languages.
• Work closely with electrical and hardware engineers to develop and troubleshoot hardware/software interfaces and integrated systems.
• Diagnose and resolve software, firmware, hardware-interface, and system-level issues.
• Participate in software architecture, requirements definition, design reviews, code reviews, and technical documentation.
• Develop and execute unit, integration, system, and regression testing.
• Support verification and validation activities and prepare appropriate engineering documentation.
• Develop scripts, utilities, automated test tools, and diagnostic applications to support engineering and manufacturing.
• Support new product development, product enhancements, sustaining engineering, and design transfer activities.
• Collaborate with Manufacturing to troubleshoot production issues and improve product test and manufacturing processes.
• Participate in Engineering Change Orders (ECOs), risk management, FMEA, and corrective/preventive actions as appropriate.
• Work with Quality Assurance and Regulatory Affairs to ensure software development activities comply with applicable medical-device standards and Company procedures.
• Support electrical, hardware, and system integration activities, including troubleshooting of analog/digital interfaces, sensors, ADC/DACs, communications, and control systems.
• Contribute to continuous improvement, technical innovation, and intellectual property activities.

QUALIFICATIONS

• Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, Software Engineering, or a related technical field.
• 5+ years of professional software engineering experience, preferably developing embedded or electromechanical systems.
• Demonstrated experience developing and maintaining software for FDA-regulated medical devices, with a strong understanding of the requirements and documentation associated with regulated product development.
• Hands-on experience working within an FDA-compliant Quality System, including software verification and validation, risk management, design controls, change control, and applicable medical-device standards such as 21 CFR Part 820 and IEC 62304.
• Strong programming experience in C/C++ and/or Python.
• Hands-on experience developing, debugging, and testing embedded software.
• Strong understanding of software development principles, debugging techniques, version control, and software testing.
• Experience working with hardware/software interfaces and troubleshooting integrated electrical, electronic, and software systems.
• Experience with embedded processors, microcontrollers, communication protocols, sensors, ADC/DAC interfaces, or control systems.
• Experience with automated testing, manufacturing test systems, diagnostic tools, or engineering utilities is preferred.
• Experience working with Git or similar source-control systems and modern software development tools.
• Familiarity with software development in a regulated environment, preferably medical devices, is highly desirable.
• Knowledge of software verification and validation, risk management, FMEA, and applicable medical-device quality standards is preferred.
• Strong analytical and problem-solving skills with the ability to independently investigate and resolve complex technical issues.
• Strong written and verbal communication skills and the ability to work effectively in a cross-functional engineering environment.

PREFERRED EXPERIENCE

• Medical device, laser, optical, electro-optical, or other highly regulated product development experience.
• Experience with real-time embedded systems and embedded Linux or RTOS environments.
• Experience with LabVIEW, Python automation, or other test/automation platforms.
• Experience with hardware debugging using oscilloscopes, logic analyzers, multimeters, and other electronic test equipment.
• Experience with electrical safety, EMC/EMI, and system-level product testing.
• Experience developing software used in manufacturing, production testing, or service/diagnostic applications.
• Knowledge of FDA-regulated product development and ISO 13485 quality systems.
  

KEY COMPETENCIES

• Embedded Software Development
• C/C++ and Python Programming
• Hardware/Software Integration
• Software Debugging & Troubleshooting
• System-Level Problem Solving
• Software Testing & Verification
• Medical Device Development
• Manufacturing & Sustaining Engineering Support
• Cross-Functional Collaboration
• Technical Documentation
• Independent Execution
• Continuous Improvement

WHAT WE OFFER

• Medical, dental, vision benefits
• Company paid group life and disability insurance
• 15 days paid vacation, 10 days paid sick time and 10 paid holidays
• 401(k) with both Traditional and Roth options
• Education reimbursement
• Professional development