Senior Design Quality Engineer (Medtech)

Location: Hybrid, with 2 days per week onsite in San Francisco, United States

Estimated pay range: $138,000–$180,000 per year

Company

hirify.global is a digital healthcare company creating wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health monitoring.

What you will do

• Support product development from concept through commercialization and post-market evaluation.
• Plan and execute design controls, risk management, and design verification and validation activities.
• Define design inputs, design outputs, and traceability matrices with engineering teams.
• Develop and maintain design history files and product risk management files.
• Review design architectures, requirements, selections, drawings, and design changes.
• Prepare technical reports, solve test-related problems, and support internal and external audits.

Requirements

• Bachelor’s degree in Computer Science, Software, Computer, Electrical, Mechanical, or Biomedical Engineering.
• At least 5 years of quality assurance experience with Class II or III medical devices containing embedded software.
• Competency in 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and other applicable international standards.
• Strong understanding of design control and risk management through commercialization.
• Experience with documentation, defect tracking, and test management tools such as Jira.
• Ability to navigate quality systems and solve complex problems with minimal oversight.

Nice to have

• Experience with electromechanical systems from concept through launch.
• Experience using MasterControl, Jira, and Jama.
• Ability to explain complex quality topics to non-experts.
• Exceptional organization and balanced, risk-based decision-making skills.

Culture & Benefits

• Patient-focused work improving cardiac health solutions.
• Collaborative, cross-functional product development environment.
• Inclusive workforce with support for qualified individuals with disabilities.
• Opportunity to contribute to products used to detect, predict, and prevent disease.