Medical Device Software Design Controls Engineer

Future Ventures; Austin (TX); On-site; USD 103,000 - 191,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid holidays

Equity (RSUs)

401(k) plan

Parental leave

Flexible time off

Commuter benefits

Meals provided

Job summary

Neuralink is seeking a Software Design Controls Engineer to own the software life cycle strategy for implantable electronics and related systems. You will ensure robust design control practices across IEC 62304, ISO 14971, and ISO 13485, collaborating with software and firmware teams to drive risk‑based mitigations.

You will develop, execute, and maintain design control deliverables, participate in design reviews, and keep documentation up to date for regulatory readiness.

Qualifications

• Experience with software design controls in medical device environments.
• Strong understanding of IEC 62304, ISO 14971, ISO 13485 requirements.
• Ability to plan, execute, review, and document software design control activities.
• Familiarity with risk management activities and FMEA/ SFMEA.

Responsibilities

• Own software design control strategy across implantable electronics and related software.
• Identify design control risks early and drive robust mitigations.
• Maintain DHF content, risk files, and traceability matrices.
• Lead end‑to‑end software lifecycle activities per IEC 62304 and related standards.
• Develop and maintain design control deliverables (plans, specs, reports).

Skills

Software design controls

Regulated SDLC

Risk management

Traceability

Design reviews

Cross-functional communication

Education

Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related technical discipline

Job description

Neuralink is seeking a Software Design Controls Engineer to own the software life cycle strategy for implantable electronics and related systems. You will ensure robust design control practices across IEC 62304, ISO 14971, and ISO 13485, collaborating with software and firmware teams to drive risk‑based mitigations.

You will develop, execute, and maintain design control deliverables, participate in design reviews, and keep documentation up to date for regulatory readiness.