Staff SaMD Software Engineer - Remote, FDA Submissions

Innolitics

Northern (KY)

Remote

USD 170,000 - 200,000

Full time

2 days ago

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Benefits offered by this job

401(k) plan with company contributions

Health insurance

Internet reimbursement up to $1,200/yr

Equipment stipend $750/yr

Job summary

Innolitics, a remote-first medical device software firm, seeks a Staff Medical Device Software Engineer who has shipped regulated software. You will lead client projects from design control through FDA submissions, write code for SaMD, and review development plans against IEC 62304.

You will draft software descriptions for 510(k), De Novo, and PMA; perform threat modeling and cybersecurity risk analysis; and mentor teams while leveraging AI coding tools daily. Remote work across the US.

Qualifications

Minimum 10+ years in a full-time software engineering role.
Direct involvement in at least one FDA submission that cleared or was approved.
Experience shipping regulated medical device software.

Responsibilities

Design and build SaMD and AI/ML device software with clean, tested code.
Write FDA software documentation: requirements, architecture, risk analysis, verification plans/reports, cybersecurity docs.
Set up and audit IEC 62304 and ISO 13485 software processes.
Prepare software sections of 510(k), De Novo and PMA submissions; respond to FDA deficiency letters.
Lead client meetings and track milestones.
Use AI coding and drafting tools daily to multiply output.