Job Description
Job Description
Iridex Corporation is a global medical technology company dedicated to advancing the treatment of glaucoma and retinal diseases through innovative laser-based solutions. Since 1989, our products have been used by ophthalmologists around the world to help preserve and improve vision.
We are looking for an experienced hands-on Software Engineering leader to head our R&D team and manage our software activities.
At Iridex, you’ll have the opportunity to contribute to meaningful work that supports physicians and patients worldwide while being part of a company that values collaboration, innovation, and continuous improvement.
PURPOSE OF JOB:
The Director, Software Engineering is the senior software engineering leader responsible for the technical direction, architecture, development, and lifecycle management of software and firmware supporting Iridex's ophthalmic medical devices.
This role serves as the organization's principal software engineering authority while providing direct leadership and management to three Principal Engineers. The Director balances hands-on technical leadership with people management, project prioritization, and cross-functional collaboration to ensure software solutions are reliable, maintainable, scalable, and aligned with product and business objectives.
The position works closely with Engineering, Quality, Regulatory, Manufacturing, Technical Service, and other functions within a regulated medical-device environment.
MAJOR DUTIES AND RESPONSIBILITIES:
Technical Leadership
- Serve as the senior technical authority for software and embedded systems across Iridex products.
- Establish software architecture, engineering standards, development practices, and technical direction.
- Lead complex software and firmware development, troubleshooting, integration, and sustaining engineering activities.
- Provide technical oversight of new product development and existing product platforms, including legacy systems.
- Review and approve software architecture, designs, code, testing strategies, and technical solutions.
- Identify and address technical risks, system-level issues, and opportunities to improve software reliability, maintainability, and development efficiency.
- Ensure software engineering activities support applicable quality, regulatory, cybersecurity, and product requirements.
- Provide hands-on technical expertise when required to resolve complex or high-priority issues.
People & Team Leadership
- Directly manage and develop three Principal Software Engineers.
- Establish team priorities, allocate resources, and balance competing technical and business requirements.
- Set clear performance expectations and provide regular coaching, feedback, and development opportunities.
- Foster a culture of accountability, collaboration, technical excellence, and continuous improvement.
- Build and maintain software engineering capabilities, processes, and technical talent to support current and future product needs.
Cross-Functional Leadership
- Partner with Product Development, Quality, Regulatory, Manufacturing, Technical Service, Sales, and other functions to resolve technical issues and deliver product objectives.
- Translate complex technical issues, risks, and recommendations into clear communication for technical and non-technical stakeholders.
- Provide technical input to engineering leadership and senior management on product strategy, priorities, risks, and resource requirements.
- Support regulatory submissions, verification and validation, cybersecurity, field issues, manufacturing activities, and other product lifecycle requirements as needed.
Engineering Operations
- Establish and maintain effective software development processes, tools, repositories, build environments, and documentation practices.
- Drive consistent software development, testing, code review, configuration management, and change-control practices.
- Ensure appropriate technical documentation and engineering records are maintained.
- Identify opportunities to improve development efficiency, product quality, and engineering infrastructure.
QUALIFICATIONS:
Education & Experience
- Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or a related technical discipline.
- 10+ years of progressive software and/or embedded systems engineering experience, with demonstrated technical leadership.
- Experience leading software engineering teams and managing senior-level technical professionals.
- Strong experience developing and troubleshooting embedded software and working at the hardware/software interface.
- Experience working in a regulated environment; medical-device experience strongly preferred.
Technical Skills
- Advanced proficiency in C and C++.
- 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 methodologies, testing, debugging, and configuration management.
- Experience troubleshooting complex software, firmware, hardware, and system-level issues.
- Familiarity with embedded cybersecurity and software development practices applicable to medical devices.
Leadership & Communication
- Demonstrated ability to lead through influence and make sound technical decisions.
- 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 Experience
- Working knowledge of FDA requirements and medical-device quality systems strongly preferred.
- Familiarity with FDA 21 CFR 820 and ISO 13485 is desirable.
- Experience supporting software verification/validation, regulatory submissions, cybersecurity, or product certification is a plus.
KEY SUCCESS FACTORS
The successful candidate will:
- Serve as the principal software engineering authority for Iridex.
- Provide strong technical direction while remaining sufficiently hands-on to solve complex problems.
- Build and lead a high-performing team of Principal Software Engineers.
- Establish scalable, disciplined, and sustainable software engineering practices.
- Successfully balance new product development, sustaining engineering, legacy systems, and urgent technical issues.
- Partner effectively across Engineering, Quality, Regulatory, Manufacturing, Technical Service, and other functions.
- Develop people while maintaining a high standard of technical excellence and accountability.
- Anticipate technical risks and proactively recommend solutions.
- Align software engineering priorities with product, customer, and business objectives.
