Principal Engineer, Quality – Design Assurance
About The Position
The Principal Engineer, Quality – Design Assurance serves as a quality engineering technical leader supporting new product development, clinical development, design transfer, and sustaining activities throughout the product lifecycle. The role partners cross-functionally with R&D, Engineering, Regulatory Affairs, Manufacturing, Clinical, Operations, and other functions to ensure appropriate application of design controls, risk management, verification and validation, and Quality Management System requirements. The Principal Engineer, Quality – Design Assurance provides independent quality oversight, leads resolution of complex technical and compliance issues, establishes and promotes quality engineering best practices, and ensures objective evidence demonstrates that product designs and manufacturing processes meet applicable user needs, design requirements, regulatory requirements, and company quality standards.
Requirements
- 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.
- Experience with software, firmware, cybersecurity, or combination-product design assurance preferred, as applicable.
- Bachelor’s degree in an engineering or science field required; advanced degree preferred.
- 7+ years of experience in medical devices.
- Experience supporting products through development, clinical use, design transfer, commercialization, and sustaining activities preferred.
- Relevant quality or regulatory certifications, such as ASQ or RAPS, preferred.
Nice To Haves
- Advanced degree preferred.
- Experience supporting products through development, clinical use, design transfer, commercialization, and sustaining activities preferred.
- Relevant quality or regulatory certifications, such as ASQ or RAPS, preferred.
- Experience with software, firmware, cybersecurity, or combination-product design assurance preferred, as applicable.
Responsibilities
- Provides design assurance leadership across the product lifecycle, including design inputs, outputs, reviews, verification, validation, transfer, and changes.
- Partners with cross-functional teams to define clear, testable requirements and maintain design-control traceability.
- Provides independent oversight of risk management activities in accordance with ISO 14971 and company procedures.
- Leads and participates in phase reviews and design reviews, ensuring actions and decisions are documented and resolved.
- Provides quality oversight for clinical and investigational device builds, including design maturity, configuration, risk, verification/validation, deviations, and changes.
- Reviews and approves verification and validation strategies, protocols, reports, acceptance criteria, and objective evidence.
- Supports qualification and validation of inspection and test methods using appropriate statistical techniques.
- Partners with Regulatory Affairs to assess regulatory impact of new products and product changes.
- Supports sustaining changes to products, suppliers, manufacturing processes, and related verification/validation activities.
- Provides quality oversight of design transfer, manufacturing readiness, supplier controls, and process validation, including IQ/OQ/PQ as applicable.
- Supports supplier selection, qualification, monitoring, development, and audits.
- Applies statistical methods to design verification, test methods, process validation, capability studies, and investigations.
- Ensures compliance with applicable QMS requirements, FDA QMSR, ISO 13485, ISO 14971, EU MDR, CMDR, and other global requirements.
- Serves as a subject-matter expert and mentor in design controls, risk management, quality engineering, and product development.
- Leads resolution of complex quality and compliance issues and drives continuous improvement.
- Performs other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
