Director of Software Engineering – FDA‑Regulated Diagnostics

Socket.dev; San Diego (CA); On-site; USD 205,000 - 220,000; Full time

Benefits offered by this job

Generous benefits

Flexible vacation

Kombucha & coffee bar

Onsite gym

Farm-to-table restaurant 30% discount

Job summary

Truvian is seeking a Director of Software Engineering to lead the software development for its FDA-cleared TruVerus blood testing platform. This onsite role requires expertise across instrument software, application software, cloud connectivity, cybersecurity, and software quality systems within an FDA-regulated product.

The ideal candidate has direct experience in managing regulated IVD or medical device software through development, verification and validation, regulatory submission,

Qualifications

• 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 with design controls, 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.

Responsibilities

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

Skills

Software leadership

FDA-regulated software

Design controls

Regulated software lifecycle

Cloud platforms (AWS/Azure/GC)

Cross-functional leadership

IEC 62304

Regulatory submissions support

Communication skills

Education

BS/MS/PhD in CS/CE/SE/EE/BME

Job description

Truvian is seeking a Director of Software Engineering to lead the software development for its FDA-cleared TruVerus blood testing platform. This onsite role requires expertise across instrument software, application software, cloud connectivity, cybersecurity, and software quality systems within an FDA-regulated product.

The ideal candidate has direct experience in managing regulated IVD or medical device software through development, verification and validation, regulatory submission,