Staff Medical Device Software Engineer (AI/ML)

Location: Remote within the United States, excluding Alaska and Hawaii

Salary: $170,000–$200,000 per year, plus a 10%–12% annual bonus tied to billing utilization targets.

Company

hirify.global develops medical device software and provides FDA regulatory consulting for healthcare clients.

What you will do

• Design and build SaMD and AI/ML medical device software with clean, tested code.
• Lead client projects from design control through FDA submission, including project planning, milestone tracking, and client meetings.
• Write software requirements, architecture, risk analysis, verification documentation, cybersecurity documentation, and software descriptions.
• Set up and audit client software processes under IEC 62304 and ISO 13485.
• Prepare software sections for 510(k), De Novo, PMA, and Pre-Submission applications and respond to FDA deficiency letters.
• Use AI coding and drafting tools daily while applying independent engineering judgment.

Requirements

• Degree in Computer Science, Biomedical Engineering, or a related field.
• 10+ years of full-time software engineering experience.
• Direct involvement in at least one FDA submission that was cleared or approved.
• Fluent coding ability in Python, C++, or TypeScript and fluent use of AI productivity tools.
• Fluent English communication through Slack, email, and video calls.
• Must live in the United States, excluding Alaska and Hawaii; willingness to travel 2–3 times per year is required.

Nice to have

• Experience with ISO 14971, IEC 62366, FDA cybersecurity guidance, AI/ML PCCPs, or Terraform-based cloud infrastructure.

Culture & Benefits

• Remote-only work since 2012.
• Projects focused on medical technologies and healthcare outcomes.
• Two hours of dedicated learning time every Wednesday afternoon.
• Opportunities to change projects and contribute beyond software development.
• 401(k) with Traditional and Roth options, including a 3% company contribution after six months.
• Company health insurance, internet reimbursement up to $1,200 per year, and a $750 annual equipment stipend.

Hiring process

• Submit an application with a three- or four-paragraph cover letter.
• Complete a couple of interviews and a take-home activity involving short documents for an imaginary medical device.
• Provide two professional references.