Software Design Control Engineer

Job Summary

We are partnering with a rapidly growing neurotechnology client in San Francisco focused on developing complex neuro devices. They are seeking a Software Design Control Engineer to support Class III medical device software from clinical development through commercialization. This role combines software engineering, quality, and regulatory compliance to ensure products are safe, compliant, and market-ready.

Responsibilities

• Create and maintain software design-control documentation, including SRS, architecture/design documents, and traceability matrices.
• Ensure compliance with IEC 62304, ISO 13485, FDA 21 CFR Part 820, and ISO 14971.
• Develop software risk documentation, including FMEAs.
• Support software V&V protocols, reports, and requirements traceability.
• Prepare technical documentation for regulatory submissions.
• Maintain software documentation through post-market activities, CAPAs, updates, and change control.

Required Qualifications

• 5+ years in medical devices, ideally with Class II or Class III software-driven products.
• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• Strong experience with DHFs, SRS, traceability matrices, and design controls.
• Experience supporting a medical device software product through FDA clearance/approval and commercial launch.

Preferred

• Strong knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA software validation guidance.
• Experience with Git and Jira.
• Experience with eQMS tools such as Greenlight Guru, Arena, Matrix Requirements, or Jama.
• Experience with post-market software changes and regulatory documentation.