Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product.
Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA.
Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes.
Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.
Manage deviation and issues for the verification and validation activities.
Support design reviews and design transfer activities including process validations, pFMEA and DMR.
Support design changes and post market activities, for example deviations and corrective and preventive actions (CAPA) to ensure product safety.
Perform risk assessments for the regulatory submissions.
Support the implementation of eQMS tools for design controls and risk management (eDHF).
Support Management reviews and internal/external audits as a subject matter expert.
Participate in process improvement initiatives as necessary, performing gap analysis.
Perform complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.

Bachelor’s degree in engineering, scientific or related field.
Minimum 6+ years of hands-on experience, or relevant comparable background.
Hands-on experience with ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971 IVDR.
Technical expertise and understanding of IVD assays and data analysis tools.
Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.

Staff Design Quality Engineer

Key skills