Director of Regulated Medical Software

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

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.