Sr. Engineering Manager (Clinical Labs - Clinical Insights)

TL;DR

Sr. Engineering Manager (Clinical Labs - Clinical Insights): Lead engineering team through full software development lifecycle for FDA 510(k) regulated medical device software with an accent on clinical insights, regulatory compliance, and AI/ML integration. Focus on decomposing clinical requirements into technical designs, ensuring cybersecurity and HIPAA compliance, and overseeing risk management and agile practices in regulated environments.

Location: Primarily remote (US locations preferred: higher-cost markets like CA, WA, NY, NJ, CT, MA, DC; other US locations), offices in Denver CO, New York NY, Dallas TX, Lisbon PT; occasional travel required for team meetings.

Base Salary: $190,000 - $219,000 (TTC: $218,000 - $251,000, varies by US location)

Company

Healthcare company revolutionizing heart disease diagnosis, treatment, and tracking with AI-driven precision diagnostic solutions.

What you will do

• Lead and support engineering team in full software development lifecycle for FDA-regulated SaMD.
• Collaborate with clinicians, regulatory, and quality teams to align development with IEC 62304, ISO 13485 standards.
• Drive decomposition of clinical/regulatory requirements into technical designs and features.
• Manage and mentor engineers in healthcare software, image processing, cardiac CT workflows.
• Integrate validated AI/ML algorithms into clinical products ensuring compliance and usability.
• Define agile practices, CI/CD pipelines, automated testing under design controls; oversee risk management.
• Participate in design reviews, audits, recruit talent in regulated domains.

Requirements

• Bachelor’s in Computer Science/Software Engineering (Master’s preferred)
• 8+ years software engineering, 2+ years management/leadership
• Experience in medical device software/healthcare tech, FDA 510(k)/CE marking
• Strong skills in Python, TypeScript/JavaScript, Node.js, React, SQL/NoSQL, RESTful/GraphQL APIs.
• AWS, IaC (Terraform/CloudFormation), AI/ML integration into production healthcare software.
• Knowledge of IEC 62304, ISO 14971, ISO 13485; thrive in fast-paced startup-like environment.

Nice to have

• Deep understanding of medical imaging (DICOM, PACS, cardiac CT).

Culture & Benefits

• Core values: Humility, Excellence, Accountability, Remarkable, Teamwork.
• Mostly remote with office access; travel for meetings (monthly/quarterly, up to 90% for some roles).
• Stock options, paid benefits, employee perks; 15% target annual bonus.
• Use Google Workspace, Slack, Confluence/Jira, Zoom.