Staff Software Quality Engineer (Medtech)

TL;DR

Staff Software Quality Engineer (Medtech): Leading the strategy, validation, and compliance of non-product software used in medical device development and manufacturing with an accent on FDA CSA guidance and ISO 13485 standards. Focus on implementing risk-based testing methodologies and ensuring compliance with 21 CFR Part 11 for GxP business processes.

Location: Hybrid in Orange County, CA (minimum 3 days on site)

Salary: $127,000 - $165,000

Company

hirify.global is a leading digital healthcare company creating trusted solutions that detect, predict, and prevent cardiac disease using wearable biosensors and cloud-based analytics.

What you will do

• Define and lead the Computer Software Assurance (CSA) strategy and validation master plans for non-product software.
• Apply risk-based testing methodologies to determine validation rigor for manufacturing, QMS, and development tools.
• Ensure all software activities comply with 21 CFR Part 11 and ISO 13485 standards.
• Review and approve validation plans, software V&V, and IQ/OQ/PQ protocols and reports.
• Lead the qualification of software-based test equipment, automated data processing systems, and design tools.
• Partner with Manufacturing, IT, DevOps, and R&D teams to implement compliant workflows.

Requirements

• Must be based in Orange County, CA (Hybrid: minimum 3 days on site).
• Minimum 12 years of related experience with a Bachelor's degree, or 8 years with a Master's degree in Computer Science or Biomedical Engineering.
• Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards, and GAMP5.
• Demonstrated experience validating custom software, DevOps toolchains (Jira, Git), and GxP applications.
• Experience implementing risk-based testing (CSA) and automated testing tools.
• Ability to lead cross-functional projects and mentor junior engineers.

Nice to have

• Experience with SaMD / AI-enabled medical devices.

Culture & Benefits

• Opportunity to grow your career while impacting global cardiac health.
• Inclusive environment that celebrates diverse backgrounds, experiences, and perspectives.
• Fast-paced culture focused on putting patients first and reimagining cardiac health.
• Professional development opportunities within a rapidly growing organization.