Senior Product Quality Assurance Engineer (hybrid)

ResMed

Base: $122,000 - $184,000; bonus/equity: not speci...
Hybrid
Bachelor's or master's degree in engineering
5 years experience with fda design controls
Knowledge of iec62304 and iec82304 standards
ResMed is seeking a Senior Product Quality Assurance Engineer to ensure the quality and safety of digital health products. The role requires a solid background in engineering, FDA design controls, and experience with digital health software, along with strong negotiation and auditing skills. The position offers a competitive benefits package and a hybrid work environment

Job Summary

  • The role ensures new and sustaining digital health products meet quality, safety standards, and regulatory requirements through specialized design controls.
  • Employees are eligible for comprehensive benefits including medical, vision, dental, life insurance, 401(k), and 15 days of Paid Time Off in the first year.
  • The position offers a competitive base salary range of $122,000 to $184,000 with opportunities for professional growth in a diverse and inclusive culture.

Matching Summary

Match Score: 85

ResMed is seeking a Senior Product Quality Assurance Engineer to ensure the quality and safety of digital health products. The role requires a solid background in engineering, FDA design controls, and experience with digital health software, along with strong negotiation and auditing skills. The position offers a competitive benefits package and a hybrid work environment.

Salary

Base: $122,000 - $184,000; Bonus/Equity: Not specified; Benefits: Comprehensive medical, vision, dental, life, 401(k), ESPP, 15 days PTO

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in engineering
  • 5 years experience with FDA design controls
  • Knowledge of IEC62304 and IEC82304 standards
  • Experience conducting internal and external audits
  • Working knowledge of AI tools like VS Code

Nice-to-have

  • Advanced knowledge of building AI agents
  • Experience creating dashboards using JIRA
  • Strong emotional intelligence and negotiation skills
  • Ability to lead sub-functional teams independently
  • Prior experience as a key backroom audit member

Key Requirements

  • Minimum 5 years experience with Bachelor's degree
  • Minimum 3 years experience with Master's degree
  • Required prior experience leading CAPAs and NCRs
  • Demonstrated risk management within design lifecycle
  • Basic to intermediate understanding of AI tools

Work Rights

Not specified

Tailored Resume

Cover Letter