Principal Design Quality Engineer (Medtech)

TL;DR

Principal Design Quality Engineer (Medtech): Ensuring innovative AI-driven cardiac diagnostic solutions meet highest standards of safety, compliance, and performance with an accent on design control activities across the full software lifecycle. Focus on leading risk management per ISO 14971, reviewing key design documentation, and embedding quality oversight into agile SDLC processes.

Location: Remote in the United States with periodic travel to office locations.

Salary: $145,000–$160,000 base with total compensation up to $184,000 including bonus.

Company

Mission-driven company building AI-powered medical technology for cardiovascular diagnosis and patient outcomes.

What you will do

• Serve as design quality engineering lead ensuring compliance with quality systems and regulations like ISO 13485, IEC 62304, FDA 21 CFR Part 820 throughout product lifecycle.
• Review and approve design control documents including requirements, architecture, verification/validation plans and reports.
• Lead risk management activities per ISO 14971 across development and post-market phases.
• Provide quality oversight for agile software processes and participate in design reviews, issue triage, CAPA investigations.
• Maintain audit-ready Design History Files and lead training on quality practices.

Requirements

• Bachelor’s degree in Engineering, Computer Science, or related field.
• 12+ years in Design Quality Engineering in medical devices, focused on software as a medical device (SaMD).
• Deep expertise in ISO 13485, IEC 62304, ISO 14971; strong understanding of FDA 21 CFR Part 820 and EU MDR.
• Experience with agile methodologies, SDLC integration, tools like GitHub, TestRail, CI/CD.
• Strong analytical, problem-solving, documentation, communication skills for cross-functional remote teams.

Nice to have

• ASQ certification (CSQE or CQE).

Culture & Benefits

• Flexible remote-first model with wellbeing perks and work-life balance support.
• Comprehensive health, dental, vision insurance; 15% performance bonus; stock options.
• Inclusive culture focused on excellence, teamwork, innovation, and mission impact.