Director, Software Engineering

ABOUT

Want to join a fast-paced, innovative company that is transforming the future of blood testing? Truvian is a healthcare technology company operating at the intersection of diagnostics and consumer technology. We have developed an automated benchtop diagnostic platform that delivers laboratory-quality results in 30 minutes or less across a broad range of health tests.

Our 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 we continue to expand access to diagnostic testing, we 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.

To us, our work at Truvian is more than a job – It’s a mission. We are a culture dedicated to discovery and empowerment. We are trailblazers on the path to put health information where it belongs - in the hands of the individual. We are partners in the belief that talented people, working as a team, can make every day an adventure.

Come join us as we realize our vision to make routine health testing convenient, affordable, and actionable for today’s connected consumers!

Truvian is seeking a Director of Software Engineering to lead software development for its recently FDA-cleared blood testing platform, Tru Verus(TM). This role will follow software development life cycle and oversee development and V&V across instrument software, application software, cloud connectivity, cybersecurity, and software quality systems in support of an FDA-regulated product. This is an ONSITE role and local candidates highly preferred.

The ideal candidate has direct experience in managing regulated IVD or medical device software through development, verification and validation, regulatory submission, commercial deployment, and post-market support.

• Unique Growth Opportunity: Gain hands-on experience across clinical studies, assay development, data analysis, regulatory submissions, and product development.
• Data-Driven Innovation: Work alongside experienced leaders, contributing to real-world healthcare solutions backed by rigorous data.
• Fast-Paced Start-Up Culture: Be part of an agile, mission-driven team where your work has immediate impact.
• Meaningful Impact: Help bring innovative diagnostic products to market that can improve patient outcomes.
• You love and thrive in a fast-paced and dynamic environment where you can implement fresh ideas, new processes, and make things happen quickly without a bunch of red tape
• You’ll have great perks such as:
  • Generous Benefits (Medical/Dental/Vision/EAP/Paid Life Insurance/LTD/401K),
  • Flexible vacation
  • Kombucha and cold brew on tap, craft coffee, a variety of healthy snacks
  • Onsite gym
  • Farm to table onsite restaurant including a 30% discount

• Software leadership: Lead software strategy, roadmap planning, architecture, development, release management, and lifecycle support for Truvian’sdiagnostic 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…