Medical Device Software Engineer (MedTech)

TL;DR

Medical Device Software Engineer (MedTech): Developing and validating software for medical devices with an accent on regulatory compliance, cybersecurity, and high-quality engineering standards. Focus on building robust software systems, drafting technical documentation for FDA submissions, and collaborating with multidisciplinary teams to improve patient safety.

Location: Must be based in the United States (excluding Alaska and Hawaii)

Salary: $120,000–$130,000 per year plus annual bonus

Company

hirify.global is a remote-only professional services firm that helps medical device companies develop software, ensure safety and security, and navigate FDA regulations.

What you will do

• Develop and maintain new medical device software according to functional and regulatory requirements.
• Guide clients through cybersecurity threat modeling and risk analysis to ensure FDA compliance.
• Collaborate with regulatory professionals to draft technical documentation, including software requirements and risk assessments.
• Conduct information gathering via interviews and source code review to validate system safety.
• Advise on configuration management, AI/ML data controls, and lifecycle management processes.
• Manage project communication and milestones as a bridge between technical and compliance teams.

Requirements

• Minimum 3+ years of experience in a full-time software engineering role.
• Fluency in Python, C++, or TypeScript.
• Must live in the United States (excluding Alaska and Hawaii).
• Degree in Computer Science, Biomedical Engineering, or related field.
• Excellent English communication skills via Slack, email, and video calls.
• Willingness to travel for company meetings a few times a year.

Nice to have

• Experience with web technologies and cloud infrastructure.
• Prior experience or interest in mobile app development.
• Knowledge of or interest in cybersecurity and FDA regulatory standards.

Culture & Benefits

• 10% annual bonus tied to performance targets.
• Comprehensive health insurance and 401(k) plan with company matching.
• Flexible work hours and fully remote culture since 2012.
• Dedicated 2 hours per week for professional development and learning.
• Equipment and internet reimbursement stipends.
• Paid time off increasing with tenure.

Hiring process

• Resume and cover letter review.
• Initial interviews.
• Take-home activity (writing documentation for an imaginary medical device).
• Reference checks.