Director, Software Engineering

Truvian Sciences•San Diego, CA

12d•$205,000 - $220,000•Onsite

About The Position

Truvian is a healthcare technology company operating at the intersection of diagnostics and consumer technology. They have developed an automated benchtop diagnostic platform that delivers laboratory-quality results in 30 minutes or less across a broad range of health tests. Their proprietary technology, which has received FDA clearance, is designed to make blood testing more accessible, convenient, and affordable by providing comprehensive results from a single small blood sample in minutes—whether in a retail setting or a private clinic. As they continue to expand access to diagnostic testing, they are actively pursuing CLIA Waiver status to further enable point-of-care testing and bring high-quality healthcare closer to where patients need it most. Truvian's mission is to put health information where it belongs - in the hands of the individual, and they are looking for talented people to join their team to realize this vision.

Requirements

BS, MS, or PhD in Computer Science, Computer Engineering, Software Engineering, Electrical Engineering, Biomedical Engineering, or related discipline.
10+ years of software engineering experience, including 5+ years leading software engineering teams.
Direct experience developing FDA-regulated medical device, IVD, diagnostic instrument, laboratory system, or point-of-care diagnostic software.
Experience working within design control, software lifecycle, risk management, verification and validation, and quality system environments.
Strong understanding of IEC 62304 and regulated software development practices.
Experience supporting commercial products after launch, including software maintenance, release management, issue resolution, and post-market support.
Experience with cloud-connected products and cloud platforms such as AWS, Azure, or Google Cloud.
Strong communication and cross-functional leadership skills in a regulated product development environment.

Nice To Haves

Experience with IVD analyzers, clinical chemistry, hematology, immunoassay, molecular diagnostics, or point-of-care diagnostic platforms.
Experience with LIS, HL7, EMR/EHR integrations, healthcare interoperability, or laboratory informatics.
Experience supporting FDA submissions, software documentation, cybersecurity documentation, audits, inspections, or software-related deficiency responses.
Experience leading external development partners or geographically distributed technical teams.

Responsibilities

Lead software strategy, roadmap planning, architecture, development, release management, and lifecycle support for Truvian’s diagnostic platform.
Ensure software requirements, risk management, design controls, verification, validation, documentation, and release activities are executed in compliance with applicable quality and regulatory requirements.
Support software for instrument control, assay execution, algorithm integration, result generation, connectivity, cloud services, customer-facing applications, and future menu expansion.
Work closely with Quality and Regulatory Affairs on FDA submissions, audits, software documentation, deficiency responses, complaint investigations, CAPAs, and post-market support.
Lead secure software development practices, vulnerability management, software updates, configuration management, product reliability, and field issue resolution.
Build, mentor, and manage a high-performing software engineering team, including internal engineers, consultants, contractors, and external development partners.
Partner with Engineering, Assay Development, Operations, Manufacturing, Field Service, Quality, and Regulatory teams to support product performance and customer experience.