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Contract Medical Device Software Engineer Jobs in Texas

Neuralink

Software Design Control Engineer

Austin, TX · On-site

... 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

Spectral MD Inc

Software Engineer

Dallas, TX · On-site

Spectral AI, Inc. (Spectral) is seeking a software engineer to join our growing design and ... Experience in medical device software development * Familiarity with regulated software ...

Spectral MD, Inc.

Software Engineer

Dallas, TX · On-site

Spectral AI, Inc. (Spectral) is seeking a software engineer to join our growing design and ... Experience in medical device software development * Familiarity with regulated software ...

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 ...

Spectral MD Inc

Cybersecurity Engineer

Dallas, TX · On-site

The Cyber Security Engineer will support the design, development, and maintenance of secure medical device software systems, ensuring that cybersecurity controls are resilient and compliant with FDA ...

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 ...

Abbott

Associate Software Engineer

Irving, TX · On-site

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll collaborate with engineers to design, build, test, and maintain software while ensuring compliance ...

Abbott

Associate Software Engineer

Irving, TX · On-site +1

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll collaborate with engineers to design, build, test, and maintain software while ensuring compliance ...

Abbott

Associate Software Engineer

Irving, TX · On-site +1

$50K - $101K/yr

What You'll Do If hired, you will help develop innovative medical device software solutions. You'll collaborate with engineers to design, build, test, and maintain software while ensuring compliance ...

Neuralink

Quality Systems Engineer

Austin, TX · On-site

... 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

Abbott

Staff Software Engineer

Irving, TX · On-site

Production medical device software with strict quality and traceability needs Your Impact * Design ... Engineering culture focused on disciplined design, testing, and quality * Direct impact on medical ...

Abbott

Staff Software Engineer

Irving, TX

Production medical device software with strict quality and traceability needs Your Impact * Design ... Engineering culture focused on disciplined design, testing, and quality * Direct impact on medical ...

Abbott

Staff Software Engineer

Irving, TX · On-site

Production medical device software with strict quality and traceability needs Your Impact * Design ... Engineering culture focused on disciplined design, testing, and quality * Direct impact on medical ...

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 · 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 ...

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Contract Medical Device Software Engineer information

What is a contract medical device software engineer?

A Contract Medical Device Software Engineer is a software professional who is hired on a temporary or project basis to design, develop, and test software used in medical devices. They typically work with manufacturers to ensure that the software meets regulatory standards, such as those set by the FDA or ISO. Responsibilities may include creating embedded software, documenting code, and collaborating with cross-functional teams to deliver safe and effective medical products. Their expertise is crucial for developing reliable software that supports patient safety and product compliance.

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

To thrive as a Contract Medical Device Software Engineer, you need a solid background in software development (C/C++/Python), embedded systems, and knowledge of medical device regulations such as IEC 62304, typically supported by a relevant engineering degree. Familiarity with development environments, version control (e.g., Git), and tools for requirements management and verification are essential, along with any certifications in medical device software or quality systems. Strong problem-solving skills, attention to detail, and effective communication are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These skills and qualifications are vital to deliver safe, compliant, and innovative software solutions efficiently in a highly regulated and dynamic industry.

What are some common challenges faced by contract medical device software engineers, and how can they be addressed?

Contract Medical Device Software Engineers often encounter the challenge of rapidly adapting to new projects, technologies, and regulatory requirements unique to each client. Working within strict timelines while ensuring compliance with FDA and ISO standards can be demanding. To address these challenges, it's important to have strong communication skills, maintain thorough documentation, and stay updated on industry regulations. Collaborating closely with cross-functional teams—including quality assurance, hardware engineers, and regulatory affairs—also helps ensure project success and smooth integration into existing workflows.

What is the difference between Contract Medical Device Software Engineer vs Medical Device Software Developer?

AspectContract Medical Device Software EngineerMedical Device Software Developer
CredentialsTypically requires a degree in software engineering, biomedical engineering, or related field; certifications like ISO 13485 or FDA compliance knowledge are commonSimilar educational background; often holds certifications in medical device regulations or quality standards
Work EnvironmentContract roles in medical device companies, often project-based, with focus on compliance and validationFull-time or freelance positions within medical device firms, focusing on software development and testing
Industry UsageCommonly hired for specific projects requiring regulatory compliance and validation expertiseInvolved in ongoing software development, maintenance, and updates for medical devices

While both roles require technical expertise in medical device software, Contract Medical Device Software Engineers typically work on short-term projects with a focus on compliance and validation, whereas Medical Device Software Developers are involved in continuous software development and maintenance within the industry.

What are the most commonly searched types of Medical Device Software Engineer jobs in Texas?

The most popular types of Medical Device Software Engineer jobs in Texas are:

What cities in Texas are hiring for Contract Medical Device Software Engineer jobs?

Cities in Texas with the most Contract Medical Device Software Engineer job openings:

Contract Medical Device Software Engineer jobs near you

Software Design Control Engineer

Neuralink

Austin, TX • On-site

Full-time

Re-posted yesterday

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

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