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Director Software Engineering Medical Device Jobs

Description Company & Job Overview Diality is a medical device company focused on developing ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

Director, Software Engineering

Irvine, CA · On-site

$223K - $260K/yr

Company & Job Overview Diality is a medical device company focused on developing solutions to ... The Director of Software Engineering reports to Director of Product Development and leads Diality ...

$186K/yr

PURPOSE OF JOB The Director, Software Engineering is the senior software engineering leader ... Experience working in a regulated environment; medical-device experience strongly preferred.

Director, Software Engineering

Tucson, AZ · On-site

$239K/yr

The Director, Software Engineering will be a strategic technology leader responsible for the design ... Excellent Benefits including medical, vision, dental, PTO, 401k, etc. * Career Progression with a ...

$216K/yr

The Director, Software Engineering will be a strategic technology leader responsible for the design, development, and delivery of software platforms supporting both digital and in-store retail ...

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Director Software Engineering Medical Device information

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$254K

How much do director software engineering medical device jobs pay per year?

As of Sep 15, 2026, the average yearly pay for director software engineering medical device in the United States is $243,917.00, according to ZipRecruiter salary data. Most workers in this role earn between $253,000.00 and $253,000.00 per year, depending on experience, location, and employer.

What does a director of software engineering in the medical device industry do?

A Director of Software Engineering in the medical device industry oversees the development and maintenance of software used in medical devices, ensuring compliance with regulatory standards such as FDA and ISO. They lead engineering teams, establish technical strategies, and coordinate cross-functional efforts to deliver safe and effective software solutions. This role also involves managing budgets, timelines, and risk assessment to support the successful launch of medical products. Additionally, they work closely with quality assurance and regulatory teams to guarantee that software meets all safety and performance requirements.

What are the key skills and qualifications needed to thrive as a director of software engineering in the medical device industry?

To thrive as a Director of Software Engineering in Medical Devices, you need deep expertise in software development, regulatory compliance (such as FDA or ISO 13485), and a background in computer science or engineering, often supported by advanced degrees. Familiarity with embedded systems, software lifecycle management tools, and quality management systems, as well as relevant certifications like PMP or Six Sigma, are highly valued. Strong leadership, communication, and problem-solving skills enable effective team management and cross-functional collaboration. These skills ensure innovative, compliant, and safe medical software products that meet industry standards and positively impact patient outcomes.

How does a director of software engineering in the medical device industry typically collaborate with cross-functional teams?

A Director of Software Engineering in the medical device sector regularly works alongside regulatory, quality assurance, hardware, and clinical affairs teams to ensure that software solutions meet both technical and compliance standards. This collaboration is essential for navigating strict regulatory requirements, such as FDA and ISO certifications, and for integrating software seamlessly with physical devices. Directors often lead interdisciplinary meetings, coordinate project timelines, and resolve technical or compliance challenges, ensuring that all teams are aligned toward successful product development and launch.

What are popular job titles related to Director Software Engineering Medical Device jobs?

For Director Software Engineering Medical Device jobs, the most frequently searched job titles are:

Infographic showing various Director Software Engineering Medical Device job openings in the United States as of September 2026, with employment types broken down into 78% Full Time, and 22% Contract. Highlights an 94% In-person, and 6% Hybrid job distribution, with an average salary of $243,917 per year, or $117.3 per hour.

Director, Software Engineering

San Jose, CA • On-site

Page Mechanical Group, Inc.
Construction • 201 - 500 employees

$296K/yr

Other

Medical, Dental, Vision, Life, Retirement, PTO

Posted 3 days ago

New


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.

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 Leadership
  • Serve 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 Leadership
  • Lead, 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 Leadership
  • Partner 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 Operations
  • Establish 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 & Experience
  • Bachelor’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 Skills
  • Advanced 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 & Communication
  • Demonstrated 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 Experience
  • Direct 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.
KEY SUCCESS FACTORS
  • Serve as Iridex’s hands-on principal software engineering authority.
  • Provide technical leadership while remaining actively involved in engineering execution.
  • Lead and develop a high-performing team of Engineers.
  • Bring disciplined medical-device software development practices to new and existing products.
  • Balance new product development, sustaining engineering, legacy systems, and urgent technical issues.
  • Partner effectively across Engineering, Quality, Regulatory, Manufacturing, and Technical Service.
  • Anticipate technical risks and drive practical solutions.
  • Align software engineering priorities with product, customer, quality, and business objectives.
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
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