Principal Design Quality Engineer

Role Overview

Principal Design Quality Engineer working in the United States, embedded within product development teams. The role bridges advanced healthcare software development with medical device design quality engineering to ensure AI-driven cardiac diagnostic software meets safety, compliance, and performance standards.

Responsibilities

• Serve as the design quality engineering lead across software development teams.
• Ensure compliance with internal quality systems and external regulatory standards across the full product lifecycle.
• Review and approve design control documentation, including:
  • User needs
  • System requirements
  • Software architecture
  • Verification & validation (plans, protocols, and reports)
• Ensure adherence to medical device software quality standards and regulations:
  • ISO 13485
  • IEC 62304
  • FDA 21 CFR Part 820
  • Other applicable global regulations
• Lead and maintain risk management activities in line with ISO 14971, including post-market surveillance.
• Provide quality oversight for agile software development and ensure compliance is embedded within the SDLC.
• Participate in design reviews, technical discussions, and issue triage to assess risk and guide prioritization.
• Support CAPA investigations and design-related complaint analysis; ensure corrective actions are implemented effectively.
• Maintain complete, audit-ready Design History Files (DHF).
• Contribute to and lead training to strengthen quality practices and regulatory awareness.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related technical discipline.
• 12+ years of experience in Design Quality Engineering or Quality Engineering in the medical device industry, with strong focus on Software as a Medical Device (SaMD).
• Deep expertise with:
  • ISO 13485
  • IEC 62304
  • ISO 14971 (hands-on application)
• Strong understanding of FDA 21 CFR Part 820; familiarity with international frameworks such as EU MDR.
• Experience integrating quality/compliance into modern software development practices (agile + SDLC).
• Familiarity with development/QA tools such as GitHub, TestRail, and CI/CD pipelines.
• Strong analytical, problem-solving, and documentation skills with high attention to detail.
• Excellent communication and collaboration across cross-functional and remote environments.

Nice to Have

• ASQ certification (CSQE or CQE).

Benefits (Summary)

• Base salary: $145,000–$160,000; total compensation up to $184,000 including bonus.
• 15% annual performance bonus eligibility.
• Stock options.
• Comprehensive health, dental, and vision insurance.
• Remote-first model with periodic travel.
• Mission-driven work on AI-powered cardiovascular diagnostic technology.