12 days ago
Base Salary
$71k - $119k/yr
Responsibilities
- Design and implement scalable software design control systems aligned with IEC 62304 and FDA requirements.
- Develop and maintain end-to-end traceability frameworks linking user needs, software requirements, risk controls, design outputs, and verification evidence.
- Integrate software risk management into design controls in alignment with ISO 14971 principles.
- Build change control mechanisms to support rapid iteration and same-day deployment.
- Partner with software engineering teams to ensure compliance with CI/CD pipelines and controlled release processes.
- Own subsets of the Quality System related to software design controls, including risk management and verification traceability.
Requirements
- 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 and software requirements management.
- Proficiency in basic scripting, automation, or querying (e.g., Python, SQL).
- Excellent written and verbal communication skills.
- Strong problem-solving mindset with a systems thinking approach.
Benefits
- Opportunity to change the world and work with talented experts.
- Growth potential with rapid advancement for impactful team members.
- Excellent medical, dental, and vision insurance through a PPO plan.
- Paid holidays and commuter benefits.
- Meals provided and equity compensation (RSUs).
- 401(k) plan and parental leave.
- Flexible time off.