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Manager Medical Device Software Engineer Jobs in Texas

Spectral MD Inc

Software Engineer

Dallas, TX · On-site

Experience in medical device software development * Familiarity with regulated software ... Comfortable managing multiple concurrent security tasks. Physical Requirements: * Prolonged periods ...

Spectral MD Inc

Cybersecurity Engineer

Dallas, TX · On-site

Cybersecurity Risk Management * Perform cybersecurity risk assessments for medical device systems ... Collaborate with software engineers to implement secure coding practices and structured code review ...

Neuralink

Software Design Control Engineer

Austin, TX · On-site

$71K - $119K/yr

Integrate software risk management into design controls, ensuring alignment with ISO 14971 ... Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes) * Familiarity with FDA ...

Revance

Project Manager, Medical Device

Dallas, TX · Remote

$8.0K - $105K/yr

We are seeking a Project Manager to support the planning and execution of medical device and ... Bachelor's degree in engineering, life sciences, or related field; advanced degree a plus. * 3-5+ ...

Neuralink

Quality Systems Engineer

Austin, TX

... regulated medical device software. These systems will support the full software lifecycle, from ... Integrate software risk management into design controls, ensuring alignment with ISO 14971 ...

Abbott

Staff Software Engineer

Irving, TX · On-site

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Production medical device software with strict quality and traceability needs Your Impact * Design ...

Abbott

Staff Software Engineer

Irving, TX · On-site

... manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott ... Production medical device software with strict quality and traceability needs Your Impact * Design ...

Neuralink

Quality Systems Engineer

Austin, TX · On-site

$71K - $119K/yr

Integrate software risk management into design controls, ensuring alignment with ISO 14971 ... Familiarity with IEC 62304 (Medical Device Software Lifecycle Processes) * Familiarity with FDA ...

Enovis

Software Engineer II

Austin, TX · On-site

Support lifecycle management of existing systems and continuous improvement of platform ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX · On-site

Support lifecycle management of existing systems and continuous improvement of platform ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX · On-site

Support lifecycle management of existing systems and continuous improvement of platform ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX

Support lifecycle management of existing systems and continuous improvement of platform ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

Enovis

Software Engineer II

Austin, TX · On-site

Support lifecycle management of existing systems and continuous improvement of platform ... Experience in medical device systems engineering or regulated environments (FDA/ISO) * Experience ...

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Manager Medical Device Software Engineer information

What are the key skills and qualifications needed to thrive as a manager medical device software engineer, and why are they important?

To thrive as a Manager Medical Device Software Engineer, you need expertise in software development, medical device regulations (such as FDA or ISO 13485), and a background in engineering or computer science, often supported by advanced degrees or certifications. Familiarity with tools like version control systems (e.g., Git), embedded systems platforms, and quality management software is essential, along with understanding regulatory documentation processes. Strong leadership, effective communication, and problem-solving abilities distinguish top performers in this role. These skills are crucial for ensuring safe, compliant, and innovative medical device software development while leading teams to deliver high-quality products.

How does a manager medical device software engineer typically collaborate with cross-functional teams during product development?

A Manager Medical Device Software Engineer frequently works alongside teams such as regulatory affairs, quality assurance, hardware engineering, clinical specialists, and marketing. They coordinate software development activities to ensure compliance with industry standards and regulatory requirements, while also aligning software features with clinical and business needs. These managers often lead design reviews, facilitate risk assessments, and ensure effective communication between software engineers and non-technical stakeholders. This collaborative environment is essential for delivering safe, effective, and user-friendly medical devices.

What does a manager medical device software engineer do?

A Manager Medical Device Software Engineer oversees teams that design, develop, and maintain software for medical devices. They ensure that the software complies with regulatory standards, works reliably, and meets the needs of healthcare professionals and patients. In addition to technical leadership, they coordinate with cross-functional teams, manage project timelines, and mentor engineers. Their role is critical in ensuring products are both safe and effective for use in medical settings.
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:
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Manager Medical Device Software Engineer jobs near you

Software Design Control Engineer

Neuralink

Austin, TX

Full-time

Re-posted 19 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