ECI · 5 hours ago
Principal Design Quality Assurance Engineer #6210
San Diego, CA
Full-time
Hybrid
Lead/Staff
8+ years expECI is a global leader in professional consulting services for the life sciences industry, providing transformative solutions to their clients. The Principal Design Quality Assurance Engineer will provide quality oversight and strategic leadership for design and development activities within the medical device lifecycle, ensuring compliance with regulatory and quality standards while driving continuous improvement in design processes.
BiotechnologyConsultingLife ScienceProject Management
No H1B
U.S. Citizen Only
Responsibilities
Provide quality and compliance input to project teams for decisions and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling)
Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards
Support Usability Engineering and planning documentation
Provide independent quality oversight for design and development activities
Ensure compliance with Design Control requirements per 21 CFR 820.30 and ISO 13485:2016
Review and approve Design History Files (DHF), Risk Management Files, and associated documentation
Lead or facilitate cross-functional Design Reviews ensuring traceability and risk alignment
Evaluate and update design-related procedures, templates, and work instructions
Support MDSAP, MDR/IVDR, and ISO 14971:2019 compliance activities and audits
Oversee risk management, ensuring consistent hazard identification and mitigation strategies
Partner with Regulatory Affairs to ensure design documentation supports regulatory submissions (510(k), CE, etc.)
Conduct internal and supplier audits specific to design and development quality
Review and approve Verification & Validation (V&V) plans and reports for accuracy and compliance
Support CAPA investigations, complaint handling, and change control related to product design
Mentor and train design and engineering teams on quality system and regulatory expectations. Drive continuous improvement initiatives and contribute to digital QMS / PLM enhancements
Other ad hoc duties as assigned
Qualification
Required
Bachelor's or Master's degree in Engineering, Life Sciences, or Quality Management
8+ years of experience in medical device design quality, design assurance, or development quality
Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, MDSAP, and EU MDR/IVDR
Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance
Experience supporting Regulatory Submissions (510(k), Technical Files, PMA)
Excellent communication, analytical, and leadership skills
Preferred
Prior consulting or contract experience in a regulated environment
Familiarity with eQMS/PLM tools such as Greenlight Guru, MasterControl, Arena, or Veeva
ASQ CQE or Six Sigma certification
Company
ECI
ECI (Enhanced Compliance Inc.) stands as a beacon of excellence in the life sciences consulting arena.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Michael Boyer
Chief Financial Officer
Shital Patel
Chief Operating Officer
Company data provided by crunchbase