San Francisco, CAremote

Salary
$170,000–$220,000
Posted
Jul 6, 2026
Location
San Francisco, CA
Last confirmed open
Jul 21, 2026

What this job asks for AI summary

A design controls-focused role at a Class III BCI medical device startup, responsible for authoring and maintaining software documentation — requirements specs, traceability matrices, risk management files, and V&V protocols — across the full product lifecycle. The position bridges software engineering and regulatory compliance, covering standards such as IEC 62304 and ISO 14971, and supporting FDA submissions as well as post-market activities. Best suited to someone with hands-on experience shepherding medical device software through FDA clearance or approval.

Senior level · 5+ years · Remote · Full-time

Must have (6)
IEC 62304ISO 13485ISO 14971Design History FilesTraceability MatricesSoftware FMEA
Nice to have (3)
GitJiraGreenlight Guru, Arena, Matrix Requirements or Jama

“or” means any one of them counts — you don't need all of them.

Posted 2 times — it's one opening, so apply once.

We read this from the posting text with AI. Skim the description below before ruling yourself out.

Why we read it this way (6)

This role is a niche hybrid of software engineering, quality systems, and regulatory compliance — it does not map cleanly to any single SOC code. 15-1299 (Computer Occupations, All Other) is used as the best available fit; 15-1211 (Computer Systems Analysts) is a plausible runner-up given the documentation and process-analysis focus.

The degree requirement (BS in CS, Biomedical Engineering, Software Engineering, or related field) is explicitly waived by 'or equivalent practical engineering experience,' so no minimum degree is flagged.

Git and Jira appear under the Preferred Qualifications heading as examples of 'modern software development workflows,' and Greenlight Guru/Arena/Matrix Requirements/Jama appear as examples of quality system tools — all treated as preferred. Greenlight Guru is listed as the primary with the others as named alternatives.

No compensation figures are provided beyond 'competitive compensation, including stock options.'

Ignored 1 non-technology phrase(s) as skills (responsibilities/concepts, not named tools): FDA 21 CFR Part 820.

Caller marked this a fully-remote role — scored against the national candidate pool.

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