Senior Medical Device Software Engineer (Medtech)

TL;DR

Senior Medical Device Software Engineer (Medtech): Developing and validating medical device software and ensuring FDA regulatory compliance with an accent on software safety, cybersecurity, and traceability. Focus on building robust software systems, implementing testing methodologies, and drafting technical documentation for regulatory submissions.

Location: Remote (US only, excluding Alaska and Hawaii)

Salary: $120,000–$150,000/year

Company

hirify.global is a remote-first company specializing in medical device software development and FDA regulatory consulting.

What you will do

• Design and develop new medical device software using Python, C++, or TypeScript.
• Construct software systems and implement robust unit and system testing methodologies.
• Guide clients through threat modeling and security risk analysis to ensure cybersecurity compliance with FDA requirements.
• Draft technical documentation, including software requirements specifications and risk assessments, for regulatory submissions.
• Collaborate with client engineers to validate system safety and document software functioning.
• Advise clients on configuration management, AI/ML data controls, and FDA-required development processes.

Requirements

• Degree (PhD, Masters, or Bachelors) in Computer Science, Biomedical Engineering, or a related field.
• 3+ years of professional experience in a full-time software engineering role.
• Fluency in Python, C++, or TypeScript.
• Must be based in the United States (excluding Alaska and Hawaii).
• English: Fluent (C1) communication skills.
• Proficiency in using AI productivity tools (e.g., Claude Code, Codex) to enhance development.

Nice to have

• Familiarity with web technologies and cloud infrastructure.
• Experience with mobile app development.
• Professional experience or strong interest in cybersecurity.

Culture & Benefits

• 401(k) with Traditional and Roth options and a 3% annual company contribution.
• Comprehensive company health insurance.
• Annual internet reimbursement up to $1,200 and an equipment stipend of $750.
• Dedicated professional development time (two hours every Wednesday afternoon).
• Remote-first work environment with annual team retreats and occasional client visits.
• Financial stability through exclusive focus on the healthcare sector.

Hiring process

• Initial review of resume and cover letter.
• A series of interviews.
• Take-home technical activity involving documentation for a hypothetical medical device.
• Two professional reference checks.