Principal Design Quality Engineer
New
C
CleerlyHealthcare
Virtual USFull-TimePrincipal
Salary145,000 - 160,000 USD per year
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Job Details
- Experience
- 12+ years of experience
- Required Skills
- TestRailAnalytical SkillsWritten communicationProblem-solving skillsVerbal communicationGitHub
Requirements
- Bachelor’s degree in engineering, computer science, or a related engineering discipline.
- 12+ years of experience in a Design Quality or Quality Engineering role within the medical device industry, with a strong focus on software as a medical device (SaMD).
- Excellent analytical and problem-solving skills with a high degree of attention to detail.
- In-depth, practical knowledge of ISO 13485, with extensive experience in Product Realization processes.
- Proven experience applying IEC 62304 (Medical device software - software life cycle processes) and ISO 14971 (Application of risk management to medical devices).
- Strong understanding of FDA Quality System Regulation (21 CFR Part 820) and familiarity with other global medical device regulations (e.g., EU MDR).
- Hands-on experience with modern software development and testing tools such as GitHub for source control, TestRail for test case management, and CI/CD pipelines.
- Strong written and verbal communication skills, with the ability to work effectively in cross-functional, remote teams.
- ASQ certification (e.g., CSQE, CQE) is a plus.
Responsibilities
- Act as the design quality engineering lead on software development project teams, providing guidance and oversight to ensure compliance with the Quality Management System (QMS) and external regulations.
- Review and approve design and development documentation, including user needs, requirements specifications, software architecture, and verification & validation (V&V) plans, protocols, and reports.
- Ensure all design control activities are compliant with ISO 13485, IEC 62304, and FDA 21 CFR Part 820.
- Facilitate, document, and maintain risk management activities according to ISO 14971 throughout the product lifecycle, from initial concept through post-market surveillance.
- Collaborate with engineering teams to ensure test methodologies are robust, effective, and well-documented for verifying and validating the software medical device.
- Maintain the Design History File (DHF) for assigned projects, ensuring they are complete, accurate, and ready for audits and regulatory inspections.
- Provide quality oversight for the software development lifecycle (SDLC) within an agile development environment, ensuring quality is built into the process.
- Participate in design reviews, technical reviews, and other project meetings to ensure quality considerations are addressed and integrated.
- Participate in software issue triage to determine risk of issues to the medical device and aid in development prioritization.
- Support the investigation of design-related complaints and contribute to Corrective and Preventive Action (CAPA) activities as required.
- Team leader who, in conjunction with management, designs and drives team-wide and company-wide training in the above areas.
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