Principal Design Quality Engineer

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Principal Design Quality Engineer in the United States.

This role sits at the intersection of advanced healthcare software development and rigorous medical device quality engineering, ensuring that innovative AI-driven cardiac diagnostic solutions meet the highest standards of safety, compliance, and performance. You will act as a senior quality leader embedded within product development teams, guiding design control activities across the full software lifecycle. The position plays a critical role in ensuring that regulated medical software is developed in alignment with global standards and regulatory requirements. You will collaborate closely with engineering, product, and regulatory teams in a highly cross-functional, agile environment. With significant influence over design decisions, you will help embed quality and risk management into every stage of development. This is a high-impact role supporting mission-driven technology aimed at improving cardiovascular diagnosis and patient outcomes at scale.

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

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Requirements

• Bachelor’s degree in Engineering, Computer Science, or a related technical discipline.
• 12+ years of experience in Design Quality Engineering or Quality Engineering within the medical device industry, with a strong focus on software as a medical device (SaMD).
• Deep expertise in ISO 13485, IEC 62304, and ISO 14971, with hands-on application in product development environments.
• Strong understanding of FDA 21 CFR Part 820 and familiarity with international regulatory frameworks such as EU MDR.
• Proven experience supporting modern software development practices, including agile methodologies and SDLC integration.
• Familiarity with development and QA tools such as GitHub, TestRail, and CI/CD pipelines.
• Strong analytical, problem-solving, and documentation skills with exceptional attention to detail.
• Excellent communication and collaboration abilities in cross-functional and remote environments.
• ASQ certification (CSQE or CQE) is a plus.

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Benefits

• Competitive base salary ($145,000–$160,000) with total compensation up to $184,000 including bonus.
• Eligibility for a 15% annual performance bonus.
• Stock options as part of the total rewards package.
• Comprehensive health, dental, and vision insurance coverage.
• Flexible remote-first work model with periodic travel to office locations.
• Employee perks and benefits supporting wellbeing and work-life balance.
• Opportunity to work on mission-driven, AI-powered medical technology with real patient impact.
• Inclusive, values-driven culture focused on excellence, teamwork, and innovation.