Sr. Engineering Manager (Medtech)

TL;DR

Sr. Engineering Manager (Medtech): Leading the development of FDA-regulated medical device software for cardiac diagnostics with an accent on clinical software lifecycle management and regulatory compliance. Focus on mentoring engineering teams, integrating AI/ML algorithms into clinical products, and ensuring system reliability under strict medical standards.

Location: Must be based in the United States. While mostly remote, some roles require on-site presence in Denver, CO, New York, NY, Dallas, TX, or Lisbon, Portugal, and occasional travel is required.

Salary: $190,000 - $219,000 (Base Salary)

Company

hirify.global is a healthcare technology company revolutionizing heart disease diagnosis and prevention through AI-driven precision diagnostic solutions.

What you will do

• Lead and support engineering teams through the full software development lifecycle for FDA 510(k) regulated medical device software.
• Collaborate with clinical, regulatory, and quality teams to ensure alignment with IEC 62304 and ISO 13485 standards.
• Manage and mentor engineers, fostering expertise in healthcare software, image processing, and cardiac CT workflows.
• Integrate validated AI/ML algorithms into clinical products while ensuring regulatory compliance, performance, and usability.
• Define and implement agile practices tailored to regulated environments, including CI/CD with validated pipelines.
• Oversee risk management activities, including software hazard analysis and mitigation.

Requirements

• 8+ years of software engineering experience, including 2+ years in management/leadership roles.
• Demonstrated experience in medical device software development (FDA 510(k) or CE marking).
• Strong programming skills in Python, TypeScript, Node.js, React, and SQL/NoSQL databases.
• Experience developing and securing RESTful and GraphQL APIs.
• Familiarity with AWS cloud services and infrastructure-as-code.
• Knowledge of IEC 62304, ISO 14971, and ISO 13485 regulatory frameworks.

Nice to have

• Deep understanding of medical imaging (DICOM, PACS, cardiac CT).
• Master’s degree in Computer Science or related discipline.
• Prior experience with Google Workspace, Slack, Confluence, and Jira.

Culture & Benefits

• Competitive base salary with a 15% target annual bonus.
• Comprehensive benefits package including stock options and paid perks.
• Collaborative, mission-driven environment focused on preventing heart attacks.
• Commitment to diversity and equal opportunity employment.
• Flexible remote-first culture with occasional team meetings and cross-functional project travel.