Principal Medical Device Software Engineer

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

Salary: $200,000–$250,000 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 companies.

What you will do

• Design and build SaMD and AI/ML medical device software with clean, tested code.
• Write software requirements, architecture, risk analysis, verification documentation, and cybersecurity documentation.
• Set up and audit client software processes under IEC 62304 and ISO 13485.
• Prepare software sections of 510(k), De Novo, PMA, and Pre-Submission applications and respond to FDA deficiency letters.
• Run threat modeling and cybersecurity risk analysis.
• Lead client meetings, define project plans, track milestones, and use AI coding and drafting tools in daily work.

Requirements

• 15+ years of full-time software engineering experience.
• At least 8 years of experience building or documenting medical device software regulated under IEC 62304, including relevant embedded firmware or software quality and V&V work combined with production coding.
• 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 tools for productivity.
• PhD, master's, or bachelor's degree in Computer Science, Biomedical Engineering, or a related field.
• Must live in the United States, excluding Alaska and Hawaii, and be able to communicate fluently in English.

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, with the ability to work anywhere in the United States except Alaska and Hawaii.
• Meaningful healthcare projects involving radiation oncology, neurosurgery, cancer tracking, and FDA-cleared AI products.
• Two hours each Wednesday afternoon dedicated to ongoing learning and opportunities to change projects.
• 401(k) plan with Traditional and Roth options; the company contributes 3% of salary after six months with immediate vesting.
• Company health insurance, internet reimbursement up to $1,200 per year, and a $750 annual equipment stipend.
• Willingness to travel two to three times per year for client visits and the annual retreat is required.

Hiring process

• Submit an application with a three- or four-paragraph cover letter describing interest, relevant regulated products, submissions, and contributions.
• The process includes resume review, several interviews, a take-home exercise writing short documents for an imaginary medical device, and two reference checks.