Director Software Engineering Truvian Sciences
Overview
Truvian Sciences seeks a Director of Software Engineering to lead software development for its FDA-cleared blood testing platform. This onsite role supports instrument software application cloud connectivity cybersecurity and quality systems for an innovative healthcare technology company. The ideal candidate will drive software strategy architecture and lifecycle management while collaborating across cross-functional teams.
What You'll Do7
- 1Lead software strategy roadmap planning architecture development release management and lifecycle support for the diagnostic platform
- 2Ensure software requirements risk management design controls verification validation documentation and release activities comply with quality and regulatory standards
- 3Provide support for instrument control assay execution algorithm integration result generation connectivity customer-facing applications and future menu expansion
- 4Partner with Quality and Regulatory Affairs on FDA submissions audits software documentation deficiency responses and post-market support
- 5Lead secure software development practices vulnerability management software updates configuration management product reliability and field issue resolution
- 6Build mentor and manage a high-performing software engineering team including engineers consultants contractors and external development partners
- 7Collaborate with Engineering Assay Development Operations Manufacturing Field Service Quality and Regulatory teams to enhance product performance and customer experience
Requirements7
- 1BS MS or PhD in Computer Science Software Engineering Electrical Engineering Biomedical Engineering or related discipline
- 210+ years of software engineering experience including 5+ years leading software engineering teams
- 3Direct experience developing FDA-regulated medical device IVD diagnostic instrument or point-of-care diagnostic software
- 4Strong understanding of IEC 62304 and regulated software development practices
- 5Experience supporting commercial products after launch including software maintenance release management issue resolution and post-market support
- 6Familiarity with cloud platforms such as AWS Azure or Google Cloud
- 7Excellent communication and cross-functional leadership skills in a regulated product development environment
Salary Insight
$205 - $220k per year
Location
Required Skills
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