Principal SaMD Software Engineer (Remote, FDA-regulated)

Innolitics; Northern (KY); Remote; USD 200,000 - 250,000; Full time

Benefits offered by this job

401(k) with employer contribution

Health insurance

Internet reimbursement

Equipment stipend

Remote-first culture

Job summary

Innolitics, a remote-first medical device software expert, is seeking a Principal Medical Device Software Engineer to lead client projects from concept to clearance. You will write code for SaMD products and assess client software development plans against IEC 62304.

In this role you will draft software descriptions for 510(k) submissions, explain FDA considerations to executives, and perform threat modeling and cybersecurity risk analyses.

Qualifications

• PhD, Masters, or Bachelors in Computer Science, Biomedical Engineering, or related field.
• 15+ years in a full-time software engineering role.
• 8+ years building or documenting software as a medical device under IEC 62304.
• Experience with FDA submissions and regulatory documentation.
• Fluent in Python, C++, or TypeScript.
• Proficient with AI tools to boost productivity.
• Willingness to travel 2–3 times per year.
• Based in the United States (excluding Alaska and Hawaii).
• Experience with ISO 14971, IEC 62366, FDA cybersecurity guidance is a plus.

Responsibilities

• Design and build SaMD and AI/ML device software with clean, tested code.
• Write FDA software documentation: requirements, architecture, risk analysis under ISO 14971, verification plans and reports, cybersecurity documentation.
• Set up and audit IEC 62304 and ISO 13485 software processes.
• Prepare software sections of 510(k), De Novo and PMA submissions and Pre-Submissions. Answer FDA deficiency letters.
• Run threat modeling and cybersecurity risk analysis.
• Lead client meetings, set project plans and track milestones.
• Use AI coding and drafting tools daily. We expect them to multiply your output, not replace your judgment.

Skills

Python

C++

TypeScript

Fluent English

AI tools

Education

PhD in Computer Science or Biomedical Engineering or related

Masters in Computer Science or Biomedical Engineering

Bachelors in Computer Science or related field

Job description

Innolitics, a remote-first medical device software expert, is seeking a Principal Medical Device Software Engineer to lead client projects from concept to clearance. You will write code for SaMD products and assess client software development plans against IEC 62304.

In this role you will draft software descriptions for 510(k) submissions, explain FDA considerations to executives, and perform threat modeling and cybersecurity risk analyses.