Staff Software Quality Engineer (Medtech)

TL;DR

Staff Software Quality Engineer (Medtech): Leading the validation and compliance strategy for non-product software used in medical device development and manufacturing with an accent on FDA CSA guidance and ISO 13485 standards. Focus on designing risk-based testing methodologies for GxP business processes and qualifying DevOps toolchains.

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

Salary: $127,000 - $165,000

Company

hirify.global is a leading digital healthcare company that creates trusted solutions to detect, predict, and prevent heart 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 and QMS tools.
• Ensure all NPS activities comply with 21 CFR Part 11 and ISO 13485 standards.
• Review and approve validation plans, software V&V, IQ, OQ, and PQ protocols/reports.
• Lead the qualification of software-based test equipment, automated data processing systems, and design tools.
• Partner with Manufacturing, IT, and DevOps teams to implement compliant workflows.

Requirements

• 12+ years of related experience with a Bachelor's degree or 8+ years with a Master's in Computer Science, Biomedical Engineering, or a related technical field.
• Deep understanding of FDA 21 CFR Part 820, Part 11, IEC 62304 standards, and GAMP5.
• Experience validating custom software, DevOps toolchains (Jira, Git), and GxP applications supporting QMS.
• Proven ability to implement risk-based testing (CSA) and use automated testing tools.
• Must be based in or be able to work hybrid in Orange County, CA with a minimum of 3 days onsite.

Nice to have

• Experience with SaMD (Software as a Medical Device) or AI-enabled medical devices.

Culture & Benefits

• Opportunity to impact the lives of patients globally through innovative cardiac health solutions.
• Collaborative and fast-paced environment focused on reimagining healthcare.
• Inclusive workforce that celebrates diverse backgrounds, experiences, and perspectives.
• Hybrid work model balancing remote and onsite collaboration.