Senior V&V / Design Quality Engineer Medical Devices Medical Devices in Plymouth,MN

Collaborate on the remediation of supplier Process FMEA (PFMEA) and internal Risk Management processes to meet regulatory compliance with FDA 21 CFR 820, ISO 13485, and ISO 14971.
Oversee the remediation of Technical Files by updating DFMEA, PFMEA, Hazard Analysis, and risk assessments, aligning with EU MDR and global regulatory standards.
Collaborated on the development and execution of system-level test strategies and verification protocols for electromechanical Class II devices, including dialysis systems.
Supervise CAPA acceleration and ensure product conformance to regulatory requirements through detailed audits, inspections, and validation activities.
Planned and performed systems-level V & V activities for electromechanical devices, documenting evidence for FDA submissions and CE technical files.
Lead electromechanical system design reviews, ensuring integration of DFM (Design for Manufacturing), DFA (Design for Assembly), and DFT (Design for Testing) principles to optimize product reliability, serviceability, and regulatory readiness.
Lead and manage Risk Analysis (DFMEA), risk control strategies (Control Plans), and review clinical data, complaints, and product labeling documentation to ensure risk mitigation strategies are met.
Develop Design History Files (DHF) and associated Design Control documents, ensuring compliance with GSPRs under EU MDR and other regulations.
Perform ongoing impact assessments for any design/material/process changes or field observations, ensuring proposed changes are thoroughly mitigated and comply with regulations.
Lead feasibility studies, defining research methodologies and design concepts to address both immediate and future customer/business needs.
Build and maintain Design History Files (DHF) and traceability to regulatory requirements, ensuring effective documentation throughout product development and submission processes.
Authored and maintained risk management documents, including DFMEA, RMR, and DTM, reflecting changes due to process and plant transitions.
Provided detailed assessments of Instructions for Use (IFUs) and labels for compliance, suggesting updates to improve usability and regulatory adherence.
Created Design transfer checklists, production readiness checklist, reviewed, and approved validations plans, protocols and Test method validations for products, equipment, and packaging validations.
Conducted gap assessments on risk management files (DFMEA, RMR, DTM) and revised documents to reflect design changes and ensure updated mitigations for potential hazards.
Managed validation projects, including equipment, process, and packaging validations, while creating readiness checklists for production activities.
Performed CAPA investigations for non-conformances, conducted root cause analysis, and implemented corrective actions to address deviations
Developed validation plans and coordinated testing to support product qualification, launch activities refinement of requirements for testability gaps, and pioneered procedures
Supported engineering activities from Design quality prospective for product and process design, including Regulatory plan, EH&S plan, risk management review, DOE, Sterility Assurance plan, design inputs, technical drawings, and specifications (BOM).
Revised Standard Operating Procedures (SOPs) and Work Instructions (WIs) as part of oncology product development involves ensuring that the processes and procedures followed are aligned with the specific requirements, regulations, and quality standards.
Ensured compliance with ISO 13485, IEC 62366 and FDA 21 CFR Part 820 by managing Design History Files (DHF) and ensuring traceability of design inputs, outputs, and verification activities throughout the product lifecycle.

Reviewed and approved drawings, IFU's, Process validation protocols (IQ, PQ, OQ and TMV's) and reports, standard operating procedures (SOP's), control plans.
Led process control and monitoring of Critical to Quality (CTQ) parameters and specifications. Implemented various product and process improvement methodologies, such as Six Sigma and Lean Manufacturing.
Supported validation projects from design quality for Existing products, new processes, and new equipment, ensuring compliance with FDA, GMP, ISO 13485, and ISO 14971 standards.