Related skills
node.js react aws sql python📋 Description
- Lead and support the engineering team through the SDLC for FDA 510(k) SaMD.
- Collaborate with clinicians, regulatory, and quality to align with IEC 62304 and ISO 13485.
- Translate clinical and regulatory requirements into actionable software designs.
- Mentor engineers in healthcare software, image processing, and cardiac CT workflows.
- Collaborate with AI/ML teams to integrate validated algorithms with regulatory compliance.
- Ensure cybersecurity, HIPAA, and FDA guidance for medical device software.
🎯 Requirements
- Bachelor’s degree in CS/Software Eng; Master’s preferred.
- 8+ years software engineering exp, 2+ in management.
- Experience in medical device software or healthcare tech, FDA 510(k) or CE.
- Python, TypeScript/JavaScript, Node.js, React, SQL/NoSQL.
- RESTful and GraphQL APIs; AWS and IaC (Terraform, CloudFormation).
- AI/ML in prod healthcare software with validation/monitoring.
🎁 Benefits
- Remote-friendly with occasional on-site needs.
- Competitive total compensation with annual bonus.
- Work on AI-driven cardiovascular care and regulated software.
- Collaborative, mission-driven culture.
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