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Medical Device Software Jobs in California (NOW HIRING)

Diality

Director, Software Engineering

Irvine, CA · Hybrid

$223K - $260K/yr

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 ...

Diality Inc

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 ...

Abbott

Software Quality Engineer

Alameda, CA · On-site

$80 - $85/hr

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering ...

Cesna Recruitment

Senior Software Engineer

San Diego, CA

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

Cesna Recruitment

Senior Software Engineer

San Diego, CA · On-site

$130K - $171K/yr

[Position] Senior Software Engineer [About Our Client] Research & Development hub for artificial ... As medical device development is iterative and subject to regulatory, technical, and business ...

1 point system

R&D Engineer Sr.

Alameda, CA · On-site

$100K - $136K/yr

Review quality system documentation products as they apply to the development, verification, validation, use, and maintenance of medical device software. Coordinate activities with other engineering ...

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All JobsMedical Device Software JobsMedical Device Software Jobs in California

Medical Device Software information

See California salary details

$21

$49

$95

How much do medical device software jobs pay per hour?

As of Jul 26, 2026, the average hourly pay for medical device software in California is $49.18, according to ZipRecruiter salary data. Most workers in this role earn between $34.62 and $58.85 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Medical Device Software Engineer, and why are they important?

To thrive as a Medical Device Software Engineer, you need strong programming abilities (often in C/C++ or Python), a solid understanding of software development life cycles, and familiarity with medical device regulations, typically backed by a degree in computer science, engineering, or a related field. Experience with development tools, embedded systems, and compliance standards like IEC 62304 or FDA requirements is highly valued. Attention to detail, problem-solving, and effective teamwork are essential soft skills in this role. These competencies ensure the creation of reliable, safe, and regulatory-compliant software critical for patient health and device performance.

What is the difference between Medical Device Software vs Medical Device Quality Assurance Specialist?

AspectMedical Device SoftwareMedical Device Quality Assurance Specialist
Required CredentialsSoftware development certifications, engineering degrees, FDA regulations knowledgeQuality assurance certifications (e.g., CQE), regulatory compliance training
Work EnvironmentSoftware development teams, R&D labs, regulatory agenciesManufacturing facilities, quality assurance labs, regulatory bodies
Employer & Industry UsageMedical device manufacturers, software firms in healthcareMedical device manufacturers, healthcare companies, regulatory agencies
Common Search & ComparisonFocuses on software development and complianceFocuses on quality processes and regulatory adherence

Medical Device Software professionals develop and maintain software used in medical devices, ensuring functionality and compliance. Medical Device Quality Assurance Specialists focus on testing, validation, and ensuring products meet quality standards. Both roles are essential in the medical device industry but differ in their core responsibilities and skill sets.

What are some common challenges faced by professionals working in Medical Device Software development?

Professionals in Medical Device Software development often navigate complex regulatory requirements, such as FDA or ISO standards, which can impact project timelines and processes. Collaborating closely with cross-functional teams—including hardware engineers, clinicians, and quality assurance specialists—is essential to ensure safety and compliance. Additionally, balancing innovation with rigorous documentation and validation can be challenging, as even minor software changes may require extensive testing and approval. Staying updated with evolving cybersecurity standards is also a key part of the role.

What is medical device software?

Medical device software is specialized software designed to be used for medical purposes, such as diagnosing, preventing, monitoring, or treating health conditions. It can be embedded within a medical device (like a pacemaker) or function as standalone software (such as mobile health apps). This software must comply with strict regulatory standards to ensure safety and effectiveness, as it directly impacts patient health and safety. Developers of medical device software must follow guidelines from authorities like the FDA or EU MDR, depending on the market. Regular updates, risk management, and comprehensive testing are also essential parts of its development process.
What are popular job titles related to Medical Device Software jobs in California? For Medical Device Software jobs in California, the most frequently searched job titles are:
What job categories do people searching Medical Device Software jobs in California look for? The top searched job categories for Medical Device Software jobs in California are:
What cities in California are hiring for Medical Device Software jobs? Cities in California with the most Medical Device Software job openings:
Medical Device Software jobs near you
Infographic showing various Medical Device Software job openings in California as of July 2026, with employment types broken down into 78% Full Time, 14% Part Time, and 8% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $102,304 per year, or $49.2 per hour.
Director, Software Engineering

Director, Software Engineering

Diality

Irvine, CA • Hybrid

$223K - $260K/yr

Other

Posted 9 days ago

Job description

Description

Company & Job Overview

Diality is a medical device company focused on developing solutions to improve lives impacted by kidney disease. Diality offers the Moda-flx Hemodialysis System, a user-friendly, mobile, and connected hemodialysis system designed to maximize clinical flexibility and ease-of-use for both clinical and non-clinical users. The Moda-flx Hemodialysis system combines flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system to provide a broad range of prescriptions and meet the needs of any professional dialysis care setting.


The Director of Software Engineering reports to Director of Product Development and leads Diality's Software Engineering and Software Verification & Validation organizations. This role serves as the functional leader for software development and software V&V activities while partnering closely with Systems Engineering, Hardware Engineering, Product Management, and other cross-functional organizations to support successful product development and lifecycle management.


The Director of Software Engineering is responsible for establishing software engineering strategy, developing high-performing organizations, guiding execution across multiple product lines, and partnering with cross-functional leaders to deliver innovative medical device solutions. The ideal candidate brings strong medical device software leadership experience, familiarity with Agile software development methodologies and V-Model SDLC, and a proven ability to build scalable engineering organizations that consistently deliver high-quality software.


Responsibilities

  • Lead and develop Software Engineering and Software Verification & Validation organizations supporting new product development, sustaining engineering, and connected medical device software systems.
  • Define and execute software engineering strategy, architecture direction, staffing and resource plans, and development priorities aligned with company objectives, product roadmaps, and regulatory requirements.
  • Establish and continuously improve software development processes utilizing Hybrid Agile methodologies and V-Model SDLC while driving execution excellence, delivery predictability, engineering metrics, and continuous improvement.
  • Provide oversight for software lifecycle activities including requirements management, architecture, implementation, integration, verification, validation, release management, sustaining engineering, and post-market software support.
  • Ensure software development and verification activities comply with applicable medical device regulations, standards, design controls, cybersecurity requirements, and company quality system requirements.
  • Partner with cross-functional leaders across Systems, Hardware, Product, Quality, Regulatory, Clinical, Manufacturing, Service, and Operations to support product development, product support, audits, inspections, and regulatory submissions.
  • Manage software organizations, employees, contractors, offshore development teams, consultants, vendors, and external development partners while fostering accountability, ownership, collaboration, innovation, and quality.
  • Recruit, develop, mentor, and retain high-performing engineering leaders and technical staff while building a strong engineering culture focused on accountability, innovation, collaboration, and continuous improvement.
  • Performs other duties as assigned


Requirements

Required Skills & Abilities
  • Demonstrated strong leadership experience managing Software Engineering and Software Verification & Validation organizations in regulated product development environments. 
  • Deep understanding of embedded software development, software architecture, complex system design, software verification, system integration, software quality practices, and medical device software lifecycle processes. 
  • Hands on experience with Object-Oriented Design principles, embedded software development, C/C++, Python, Linux-based systems, BSP, bare-metal hardware/software integration, software debugging, and software lifecycle tools such as Jira, Jama, or equivalent platforms. 
  • Experience leading software organizations utilizing Agile, Scrum, or V-Model, including practical sprint planning, execution, requirements traceability, risk management, verification, validation, and release processes. 
  • Experience establishing and overseeing software development processes, engineering practices, and development organizations within regulated product development environments. 
  • Experience with medical device software cybersecurity activities, including secure software development practices, threat modeling, vulnerability management, cybersecurity risk management, and regulatory compliance. 
  • Ability to lead software organizations and deliver results in fast-paced, dynamic product development environments with evolving priorities and aggressive timelines. 
  • Strong strategic thinking, leadership, communication, organizational, and stakeholder management skills with experience leading software organizations and external software engineer contractors. 
  • Familiarity with cloud-connected medical device systems, mobile applications, interoperability, healthcare data platforms, and device-to-cloud communication architectures is a plus. 
  • Strong understanding of IEC 62304, ISO 14971, FDA software validation expectations, medical device cybersecurity guidance, and design controls.

Education & Experience
  • Bachelor's or Master's degree in Computer Science, Software Engineering, Computer Engineering, Electrical Engineering, or a related technical discipline.
  • 15+ years of software engineering experience with progressively increasing technical and leadership responsibilities, including significant experience in regulated product development environments.
  • Minimum of 7 years of formal leadership experience managing software engineering teams.
  • Experience leading software development for complex embedded electromechanical systems within medical device industry
  • Experience developing embedded software for hemodialysis systems or other complex Class II or Class III medical devices is highly preferred. 
  • Demonstrated success leading Software Engineering and Software Verification & Validation organizations supporting both new product development and sustaining engineering activities.
  • Proven track record delivering complex embedded medical device products from concept through verification, validation, regulatory clearance, manufacturing release, commercialization, and post-market support.
  • Experience building and managing high-performing software organizations utilizing employees, contractors, offshore development teams, and external development partners.
  • Experience supporting FDA submissions, audits, inspections, design controls, and software lifecycle compliance activities for Class II or Class III medical devices.

Travel
  • Ability to travel (domestic and international) as required, approximately 10%

Physical Requirements
  • Prolonged periods of sitting at a desk and working on a computer
  • May be expected to lift 15 pounds at times

The information contained in this job description is for compliance with the Americans with Disabilities Act (ADA) and is not an exhaustive list of duties performed for this position.

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