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2 months ago

Sr. Engineering Manager (Medtech)

190 000 - 219 000$
Work format
remote (only USA)/onsite
Work type
fulltime
Grade
lead
English
b2
Country
US
This vacancy is from Hirify.Global listVacancy from Hirify Global, list of international tech companies
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Job description

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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.

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