Principal Design Quality Engineer
New
USFull-TimePrincipal
Salary145,000 - 160,000 USD per year
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Job Details
- Experience
- 12+ years of experience
- Required Skills
- TestRailAnalytical SkillsCollaborationAgile methodologiesProblem-solving skillsGitHub
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.
Responsibilities
- 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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