Director, Software Engineering

About the Company: Iridex is a global ophthalmic medical device company dedicated to advancing innovative laser-based solutions that help physicians treat sight-threatening eye diseases. With decades of experience in ophthalmology, Iridex develops and delivers clinically focused technologies used by eye-care professionals around the world. As the company continues to evolve, we are building a more focused, accountable, and high-performing organization where talented people can have a meaningful impact. This is an opportunity to join a lean, collaborative team and play a key role in advancing technologies that directly improve patient care and preserve vision. The Opportunity: The Director, Software Engineering is Iridex’s senior, hands-on software engineering leader, responsible for the technical direction, architecture, development, and lifecycle management of software and firmware supporting ophthalmic medical devices. This is a hands-on R&D leadership role, not solely a people-management position. The successful candidate must be capable of personally engaging in software architecture, development, code review, debugging, and system-level troubleshooting while leading the broader R&D Engineering team. The Director serves as Iridex’s principal software engineering authority while leading, managing, and developing the R&D Engineering team. The role requires demonstrated experience developing software and embedded systems for regulated medical devices and working across the product lifecycle in partnership with Engineering, Quality, Regulatory, Manufacturing, and Technical Service What You'll Do:Technical & Hands-On Engineering LeadershipServe as the senior technical authority for software, firmware, and embedded systems.Define software architecture, engineering standards, development practices, and technical direction.Remain hands-on in software design, development, code review, debugging, integration, troubleshooting, and resolution of complex system-level issues.Lead new product development, sustaining engineering, and legacy-system activities.Identify and mitigate technical risks and improve software quality, reliability, maintainability, and development efficiency.Ensure software development meets applicable medical-device quality, regulatory, cybersecurity, and product requirements.R&D Engineering LeadershipLead, manage, and develop the R&D Engineering team, including senior and Principal-level engineers. Set priorities, allocate resources, and balance technical and business requirements.Establish clear performance expectations and foster a culture of accountability, collaboration, and technical excellence.Develop engineering capabilities, processes, and talent to support current and future product needs.Cross-Functional LeadershipPartner with Engineering, Quality, Regulatory, Manufacturing, Technical Service, Product Management, and other functions to deliver product objectives and resolve technical issues.Provide technical input on product strategy, priorities, risks, and resource requirements.Support product development, verification and validation, regulatory submissions, cybersecurity, manufacturing, and field-support activities.Communicate complex technical issues, risks, and recommendations effectively to technical and non-technical stakeholders.Engineering OperationsEstablish and maintain effective software development, testing, code review, configuration management, documentation, and change-control practices.Drive improvements in development tools, processes, infrastructure, and engineering efficiency Qualifications:Education & ExperienceBachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or related technical discipline.10+ years of progressive software and/or embedded systems engineering experience, including significant hands-on experience developing software for regulated medical devices.Demonstrated experience leading software engineering teams and managing senior-level technical professionals.Strong experience with embedded software development and hardware/software integration.Experience working across the medical-device product lifecycle, including development, verification/validation, sustaining engineering, and product support.Demonstrated experience working within medical-device quality and design-control processes.Technical SkillsAdvanced proficiency in C and C++ with significant hands-on embedded software development experience.Strong experience with embedded systems, including ARM and/or TI C2000 processors.Experience with bare-metal embedded development and Linux and/or Windows environments.Strong understanding of software architecture, development, testing, debugging, and configuration management.Demonstrated ability to troubleshoot complex software, firmware, hardware, and system-level issues.Familiarity with embedded cybersecurity and medical-device software development practices..Leadership & CommunicationDemonstrated experience leading R&D or engineering teams and managing senior-level technical professionals.Strong people-management, coaching, and team-development skills.Excellent written and verbal communication skills.Ability to communicate effectively with engineers, executives, regulatory professionals, manufacturing personnel, and other stakeholders.Strong analytical, problem-solving, prioritization, and decision-making skills.Ability to operate effectively in a dynamic environment with changing technical, regulatory, manufacturing, and business priorities.Medical Device / Regulatory ExperienceDirect experience developing software for FDA-regulated medical devices is required.Working knowledge of medical-device software lifecycle, design controls, risk management, verification/validation, and change control.Familiarity with FDA requirements and standards such as IEC 62304, ISO 13485, and ISO 14971.Experience supporting regulatory submissions, software documentation, cybersecurity, or product certification is a plus. What We Offer:Medical, dental, vision benefitsCompany paid group life and disability insurance15 days paid vacation, 10 days paid sick time and 10 paid holidays401(k) with both Traditional and Roth optionsEducation reimbursementProfessional development Work Location: Onsite | San Jose, CASalary Range: $240K - $245K