
11 - 50 employees
Founded 2025
π₯ Healthcare
π Compliance
βοΈ SaaS
Healthcare β’ Compliance β’ SaaS
Infera is an AI-native medtech compliance platform that centralizes design history, requirements, risk analysis, verification, release/version control, and document change management into a single, integrated SaaS. It automatically imports and traces requirements from PDFs, PRDs, Jira, images and source code or architecture diagrams, performs ISO 14971-compliant hazard analyses with agent-assisted risk scoring and mitigation suggestions, generates and tracks test protocols and coverage, and manages approvals, e-signatures, and controlled documents for regulatory evidence (DHF/TD). The product targets organizations across startup to enterprise stages with FDA-ready templates, integrations to common development and cloud tools, and adherence to standards such as ISO 13485, ISO 14971, and IEC 62304; it is SOC 2 Type II compliant.
π₯ 15 minutes ago
π California, New York β Remote
π΅ $160k - $180k / year
β° Full Time
π Senior
π§βπ» Full-stack Engineer
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11 - 50 employees
Founded 2025
π₯ Healthcare
π Compliance
βοΈ SaaS
Healthcare β’ Compliance β’ SaaS
Infera is an AI-native medtech compliance platform that centralizes design history, requirements, risk analysis, verification, release/version control, and document change management into a single, integrated SaaS. It automatically imports and traces requirements from PDFs, PRDs, Jira, images and source code or architecture diagrams, performs ISO 14971-compliant hazard analyses with agent-assisted risk scoring and mitigation suggestions, generates and tracks test protocols and coverage, and manages approvals, e-signatures, and controlled documents for regulatory evidence (DHF/TD). The product targets organizations across startup to enterprise stages with FDA-ready templates, integrations to common development and cloud tools, and adherence to standards such as ISO 13485, ISO 14971, and IEC 62304; it is SOC 2 Type II compliant.
β’ Own significant surface area across our product β from the app our customers use daily, to the services that power AI workflows over their quality system. β’ Make architectural calls, help set the bar for the team, and ship things that directly affect how the next wave of medical devices gets to patients. β’ Lead end-to-end delivery of meaningful product areas. β’ Design schemas, APIs, and frontend data flows that hold up under real customer load and regulatory scrutiny. β’ Work directly with the founders and customers; translate ambiguous problems into released software. β’ Mentor other engineers through code review, pairing, and design discussions.
β’ 6+ years building production web applications, with real depth on both sides of the stack β’ Mastery over SOTA AI tooling β’ Strong React + TypeScript and strong Python β’ Experience designing relational schemas, background jobs, and multi-tenant architectures β’ A strong track record of delivering with quality in mind. Experience in end-to-end QA Automation is strongly preferred. β’ Track record of owning systems from design through production operation β’ DevOps & Cloud Infrastructure experience preferred (designing, building, and operating production systems on AWS or GCP) β’ A bias toward shipping
β’ Competitive salary + meaningful equity β every engineer is an owner β’ Health/dental
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