Principal Engineer, Quality – Design Assurance
$138,000–$150,000 year
On-siteRancho Cucamonga, California, United States
Job Summary
Lead design assurance across the product lifecycle, managing design inputs, outputs, reviews, verification, validation, transfer, and changes. Partner with cross-functional teams to define testable requirements, maintain design-control traceability, and provide independent oversight of risk management, clinical builds, and regulatory impacts. Review and approve validation strategies, protocols, and objective evidence while supporting supplier qualification, process validation, and sustaining changes. Apply statistical methods to capability studies and investigations, ensuring compliance with FDA QMSR, ISO 13485, and ISO 14971. Serve as a subject-matter expert in design controls and risk management to drive continuous improvement and resolve complex quality issues.
Required Qualifications
- Bachelor's degree in an engineering or science field
- 7+ years of experience in medical devices
- Expert knowledge of medical device design controls, risk management, verification/validation, design transfer, and product development
- Demonstrated technical leadership, cross-functional influence, problem solving, and risk-based decision making
- Strong knowledge of FDA QMSR, ISO 13485, ISO 14971, and other applicable medical device requirements
- Strong technical writing and review skills for protocols, reports, risk files, requirements, and design-control records
- Strong statistical knowledge and experience with Minitab or equivalent statistical software
- Excellent written, verbal, presentation, collaboration, and interpersonal skills
- Strong project management, prioritization, analytical, and problem-solving skills
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Must be able to remain in a stationary position at least 50% of the time, including sitting at a desk and working on a computer
- Occasionally move about inside the office and travel to and from office buildings. This may include, but is not limited to, bending and walking
- Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc
- Occasionally lift up to 15 pounds. This may be performed with reasonable accommodation
- Ability to listen and speak with others. Must be able to exchange accurate information in these situations
- View and type on computer screens for long periods of time
Desired Qualifications
- Advanced degree
- Experience supporting products through development, clinical use, design transfer, commercialization, and sustaining activities
- Relevant quality or regulatory certifications, such as ASQ or RAPS
- Experience with software, firmware, cybersecurity, or combination-product design assurance
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