Director, Software Engineering

Truvian Sciences; San Diego (CA); On-site; USD 205,000 - 220,000; Full time

Job summary

Truvian Sciences is seeking a Director of Software Engineering to lead software development for its FDA-cleared TruVerus platform. This onsite role will oversee instrument software, application software, cloud connectivity, cybersecurity, and software quality systems in support of an FDA-regulated product.

The ideal candidate has 10+ years in software engineering, with 5+ years leading teams, and direct experience with regulated medical device software, design controls, and cloud platforms.

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 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.

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 compliant with quality and regulatory requirements.
• Provide software support for instrument control, assay execution, algorithm integration, result generation, connectivity, cloud services, and customer-facing applications.
• Collaborate with Quality and Regulatory Affairs on FDA submissions, audits, software documentation, and post-market support.
• Drive secure software development practices, vulnerability management, software updates, and configuration management.
• Build, mentor, and manage a high-performing software engineering team across internal and external partners.
• Partner with cross-functional teams to support product performance and customer experience.

Skills

Software leadership

Regulated software

Cloud platforms

Team leadership

IEC 62304

Education

CS/Engineering degree

Job description

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!

JOB SUMMARY

Truvian is seeking a Director of Software Engineering to lead software development for its recently FDA-cleared blood testing platform, TruVerus(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.

HERE’S WHY YOU’LL LOVE THIS JOB:

• 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
  
  
  
  

WHAT YOU WILL DO:

• Software leadership: Lead software strategy, roadmap planning, architecture, development, release management, and lifecycle support forTruvian’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 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.

WHAT YOU WILL BRING:

• 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-HAVE QUALIFICATIONS

• 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.

SUPERVISORY ROLE

• Yes

SALARY RANGE

$205,000 – $220,000

The salary range for this position represents the anticipated range for qualified candidates. Compensation decisions are based on a variety of factors, including relevant experience, skills, education, training, certifications, internal equity, market data, and business needs. The final compensation offered to a successful candidate will be determined based on these factors and the requirements of the role.

PHYSICAL DEMANDS AND ABILITIES

• Ability to safely lift, carry, and move materials weighing up to 5 pounds on a regular basis.


• Ability to remain stationary and move about the work environment as needed to perform job duties.


• Ability to perform visual tasks associated with the position, including reviewing data, inspecting materials, and operating laboratory or computer equipment, as applicable.


• Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions of the position.

Truvian is an Equal Opportunity Employer and is committed to fostering a diverse, inclusive, and respectful workplace. Employment decisions are made based on qualifications, merit, and business needs. Truvian prohibits discrimination, harassment, and retaliation and does not discriminate on the basis of any characteristic protected by applicable federal, state, or local law, including race, color, religion, creed, sex, pregnancy (including childbirth, breastfeeding, and related medical conditions), gender, gender identity, gender expression, sexual orientation, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, reproductive health decision-making, or any other legally protected status.

This policy applies to all aspects of employment, including recruitment, hiring, placement, promotion, compensation, benefits, training, transfers, leaves of absence, disciplinary actions, termination, and all other terms and conditions of employment. Truvian is also committed to providing reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs, practices, or observances, in accordance with applicable law.