Software Design Control Engineer
$71,000–$119,000 year
On-site · Austin, Texas, United States
Job Summary
As a Software Design Controls Engineer, design, implement, and continuously improve software-focused design control systems with regulatory compliance embedded into their architecture. Build systems that enable rapid, reliable development of regulated medical device software across the full software lifecycle (requirements through verification, validation, risk management, and release). Align design controls with IEC 62304 and FDA design control requirements, integrate software risk management per ISO 14971, enable automated evidence generation within CI/CD pipelines, and support rapid iteration and same-day deployment. Collaborate with software teams on compliance and controlled release processes, owning software design control processes, software risk management, change control, and traceability. Base salary range: $71,000—$119,000 USD; full-time benefits include equity eligibility (RSUs) and comprehensive health, retirement, and other perks.
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
Desired 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
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