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Medical Device Software Engineer Jobs in Austin, TX

Neuralink

Software Design Control Engineer

Austin, TX · On-site

$71K - $119K/yr

Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes) * Familiarity with FDA ... Software Design Controls Engineer * Software Quality * Regulated software development Expected ...

Neuralink

Quality Systems Engineer

Austin, TX

... regulated medical device software. These systems will support the full software lifecycle, from ... Partner closely with software engineering teams to embed: * Compliance with CI/CD pipelines

Neuralink

Quality Systems Engineer

Austin, TX · On-site

$71K - $119K/yr

We focus on embedding compliance directly into engineering workflows rather than treating it as a ... Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes) * Familiarity with FDA ...

Enovis

Software Engineer II

Austin, TX · On-site

Software Engineer II Location: Austin, Texas Job Title/High Level Position Summary: * We are ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX · On-site

Software Engineer II Location: Austin, Texas Job Title/High Level Position Summary: * We are ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX

Software Engineer II Location: Austin, Texas Job Title/High Level Position Summary: * We are ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX

Software Engineer II Location: Austin, Texas Job Title/High Level Position Summary: * We are ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX · On-site

Software Engineer II Location: Austin, Texas Job Title/High Level Position Summary: * We are ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Senseye

Design Quality Engineer, SaMD

Austin, TX · On-site

$100K - $125K/yr

We are looking for a Design Quality Engineer for our software medical device (SaMD) who can partner closely with engineering, clinical, regulatory, and product teams to build practical, audit-ready ...

Mackenzie Health Care

Embedded Software Enginner

Austin, TX

$130K - $171K/yr

... Medical Device, Diagnostics, Biotech, Research, Lab), Six Sigma/Lean, Finance/Accounting, Sales, and Marketing, Consumer, Mobile Technology and Social Media. Growing Strong Companies with the very ...

Mackenzie Health Care

Embedded Software Enginner

Austin, TX · On-site

$130K - $171K/yr

... Medical Device, Diagnostics, Biotech, Research, Lab), Six Sigma/Lean, Finance/Accounting, Sales, and Marketing, Consumer, Mobile Technology and Social Media. Growing Strong Companies with the very ...

Danaher

Software Engineer Internships

Austin, TX · On-site

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

Danaher

Software Engineer Internships

San Marcos, TX · On-site

Producing documentation to support medical device regulatory processes Who This Is For * Students graduating in 2026 or later with a Bachelor's degree in Computer Science, Software Engineering ...

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Showing results 1-20

All JobsMedical Device Software Engineer JobsMedical Device Software Engineer Jobs in Austin, TX

Medical Device Software Engineer information

See Austin, TX salary details

$62.9K

$146.2K

$203.6K

How much do medical device software engineer jobs pay per year?

As of Aug 10, 2026, the average yearly pay for medical device software engineer in Austin, TX is $146,192.00, according to ZipRecruiter salary data. Most workers in this role earn between $118,900.00 and $171,400.00 per year, depending on experience, location, and employer.

How do you become a medical device software engineer?

To become a medical device software engineer, individuals typically need a bachelor's degree in software engineering, computer science, or a related field. Experience with embedded systems, programming languages like C or C++, and knowledge of medical device regulations such as FDA standards are important. Certifications in quality management or regulatory compliance can also enhance job prospects.

What are the key skills and qualifications needed to thrive as a medical device software engineer?

To thrive as a Medical Device Software Engineer, you need a solid background in software development, embedded systems, and biomedical engineering, often supported by a degree in computer science, electrical engineering, or a related field. Experience with programming languages like C/C++, knowledge of real-time operating systems, and familiarity with medical device regulatory standards such as IEC 62304 are typically required. Strong problem-solving skills, attention to detail, and effective communication are essential soft skills for this position. These skills ensure high-quality, compliant software that contributes to safe and reliable medical devices, which are critical for patient health.

What is a medical device software engineer?

A Medical Device Software Engineer is responsible for designing, developing, testing, and maintaining software used in medical devices. They ensure compliance with regulatory standards like FDA and IEC 62304 while working on embedded systems, user interfaces, or cloud-based healthcare applications. Their role involves collaborating with cross-functional teams, including hardware engineers and regulatory specialists, to ensure patient safety and product effectiveness.

What are the typical daily responsibilities of a medical device software engineer?

Medical Device Software Engineers typically spend their days designing, coding, and testing software for medical devices in compliance with health regulations. They collaborate closely with hardware engineers, quality assurance teams, and regulatory specialists to ensure that the software integrates seamlessly with device hardware and meets performance and safety standards. Documenting development processes, participating in code reviews, and addressing feedback from cross-functional teams are also common aspects of the role. This position often requires troubleshooting issues in both simulated and real clinical environments to ensure the reliability and safety of the device.

What are popular job titles related to Medical Device Software Engineer jobs in Austin, TX? For Medical Device Software Engineer jobs in Austin, TX, the most frequently searched job titles are:
What job categories do people searching Medical Device Software Engineer jobs in Austin, TX look for? The top searched job categories for Medical Device Software Engineer jobs in Austin, TX are:
Medical Device Software Engineer jobs near you
Infographic showing various Medical Device Software Engineer job openings in Austin, TX as of August 2026, with employment types broken down into 90% Full Time, and 10% Contract. Highlights an 88% In-person, 5% Hybrid, and 7% Remote job distribution, with an average salary of $146,192 per year, or $70.3 per hour.

Software Design Control Engineer

Neuralink

Austin, TX

Full-time

Re-posted 22 days ago

Job description

Team Description:

Join the Quality Systems Team, where our mission is to ensure compliance with applicable regulatory standards by designing scalable, efficient, and automation-driven systems. We focus on embedding compliance directly into engineering workflows rather than treating it as a manual or reactive function.

We are a team of industry-experienced professionals who apply systems thinking and creative problem-solving to build a durable compliance infrastructure that supports rapid development. Our vision is to establish internal design and quality systems that exceed FDA expectations while enabling fast iteration and deployment of complex, safety-critical software products.

Job Description and Responsibilities:

Please note, this is a duplicate posting for the "Quality Systems Engineer" role. We are testing titling to see which attracts the most qualified candidates. Please only apply to one of the postings. 
As a Software Design Controls Engineer, your primary responsibility will be to design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture.

You will build systems that eliminate ambiguity, reduce manual effort, and enable rapid and reliable development of regulated medical device software. These systems will support the full software lifecycle, from requirements definition through verification, validation, risk management, and release.

You will continuously optimize these systems to improve speed, traceability, and audit readiness while supporting aggressive development timelines and frequent design changes. Your responsibilities include, but are not limited to:

  • Design and implement scalable software design controls systems aligned with IEC 62304 and FDA design control requirements (21 CFR 820.30)
  • Develop and maintain end-to-end traceability frameworks linking:
    • User needs
    • Software requirements
    • Risk controls
    • Design outputs (code, architecture)
    • Verification and validation evidence
  • Integrate software risk management into design controls, ensuring alignment with ISO 14971 principles
  • Build change control mechanisms capable of supporting:
    • Rapid iteration
    • Parallel development
    • Same-day deployment
  • Partner closely with software engineering teams to embed:
    • Compliance with CI/CD pipelines
    • Automated evidence generation
    • Controlled release processes
  • Own subsets of the Quality System related to software design controls, including but not limited to:
    • Software Design Control processes
    • Software Risk Management
    • Software Change Control
    • Software Verification & Validation traceability

Required Qualifications: 

  • Bachelor's degree in Electrical Engineering, Computer Science, or a related technical field
  • Demonstrated experience designing or maintaining structured engineering or compliance systems
  • Familiarity with software development lifecycles in regulated or safety-critical environments
  • Working knowledge of:
    • Design Controls
    • Software requirements management
    • Proficiency in basic scripting, automation, or querying (e.g., Python, SQL, or equivalent)
  • Excellent written and verbal communication skills
  • Strong problem-solving mindset with the ability to think in systems rather than silos

Preferred Qualifications:

  • Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes)
  • Familiarity with FDA Design Controls (21 CFR 820.30)
  • Familiarity with Design Risk Management (ISO 14971 principles)
  • 1-3 years of experience in:
    • Software Design Controls Engineer
    • Software Quality
    • Regulated software development

Apply