Design Documentation Management:Actively manage ongoing review and assessment of design documentation for NPD.Ensure Design History Files (DHF), drawings, specifications, and quality control plans meet quality standards.Non-Conformities (NCs) and Corrective Actions (CAPAs):Own multiple NCs and CAPAs identified during design transfer activities.Ensure resolution and compliance with regulatory requirements and standards.Regulatory Compliance:Ensure design transfer process compliance with regulatory requirements.Verify alignment with ISO 13485 and FDA regulations.Test Procedures and Inspection:Develop test procedures and update inspection checklists.Perform de-risking for First Article Inspections (FAIs).Process Verification Activities:Conduct MSA studies, Gage R&R, capability studies for process verification.Continuously assess risks during design transfer, develop mitigation strategies.Design Control Adherence:Manage adherence to established design control processes in design transfer.Ensure completeness and accuracy of relevant design control documentation.Validation and Verification Activities:Lead ongoing validation and verification activities for design transfer.Ensure consistent testing and documentation per established protocols.Supplier and Vendor Collaboration:Collaborate with suppliers and vendors.Ensure manufacturing processes are well defined, validated, and meet quality and regulatory standards consistently.

Lead New Product Development (NPD)Design and Development Leadership:Collaborate with project stakeholdersFacilitate Design Control and Risk Management ProcessStructured Development Approach:Implement interdisciplinary development approachIdentify design and user needs for NPITechnical Risk Management:Identify and manage technical risksMake design decisions, bridge functional gapsEU MDR Strategy:Address EU MDR requirements for new productsOwn EU MDR design control, DHF, verification, validationDHF Updates and Remediations:Lead EU MDR DHF updates for Knee/Spine ImplantsWork on Risk Management, Design Verification, Statistical MethodsBSI Submissions:Create Tech Files for BSI submissions (Knee Implants)Serve as primary development engineer for BSI submissionsCross-Functional Collaboration:Coordinate with engineering, regulatory, marketing, etc.Review and approve development documentationRisk Mitigation:Actively collaborate to mitigate risksProvide adequate documentation for risk managementDocumentation and Compliance:Write Technical Memos, ORs, compliance assessmentsUpdate legacy product DHF for EU MDR compliancePost Market Data Analysis:Analyze post-market dataUpdate design inputs and outputs based on analysis

EtQ Reliance Usage:Managed NCs using EtQ Reliance for product/non-product issues.CAPA Processes Oversight:Managed Investigations CAPA Processes for non-conformances, audits, and cross-functional departments.Equipment Validation:Ensured Equipment Validation (IQ, OQ, PQ) and conducted Periodic Validation Activities.Performed TMVs.Root Cause Analysis and Correction:Conducted immediate correction activities.Identified root causes using tools (5Whys, 6Ms, Process flow diagrams).Implemented Action plans, monitored Effectiveness Monitoring Plans.Audits and Reviews:Led audits, QMS reviews, CAPA Review Board, Material Review Board, gathered metrics.Receiving Inspection Management:Managed Engineering & Project Management in Receiving Inspection.Design History Documentation:Initiated, approved, controlled changes to design history documentation.Updated Design Controls, conducted Design Verification and Validation.Monitored DHF requirements in line with project timeline, design control.Trend Analysis and Surveillance:Conducted trend analysis for post-market surveillance, updated design and quality records.Leadership in Issues:Provided leadership/support on process, product issues.Assisted as local expert in automation, robotics, maintenance, calibration, vision systems.Lean Methodology and Projects:Implemented Lean methodology for quality, compliance, efficiency, yield, throughput improvements.Protocols and Reports Review:Reviewed protocols, reports for processes development experimentation.Performed FAI, approved warrants for program products.Supplier Change Notification (SCN) and Corrective Actions:Worked on Supplier Change Notification (SCN) for changes.Ensured Supplier Corrective Action Plans, initiated SCAR for part discrepancies.Labware LIMS Project Management:Managed $1.5M Labware LIMS project, ensured data migration, system integration.Maintained master data, conducted training, collaborated on Computer System Validation activities.

Testing for Catheters:Conducted Dimensional, Leakage, and flow rate testing for Airway Exchange Catheters and Cardiovascular catheters.Test Method Validation (TMV):Wrote and executed TMV for various catheters (Intravascular, Airway Exchange, Angiographic, Balloon), Flexor Tubing, Sheaths, Stone Extractors, Micro puncture introducer set (MPIS), Ansel, Guidewires, Dilators, Hypodermic Syringes, and Packaging.Documentation and Training:Wrote Controlled Training documents, TMV Plans, Protocols, and Reports.Included Attribute and Variable TMVs for Destructive and Non-Destructive testing.New Test Methods and Inspections:Identified new test methods.Controlled inspections, self-evident inspections, Visual, and Manual Inspections.Statistical Analysis:Performed Gage R&R (Crossed, Nested), ANOVA studies for Variable TMVs.Analyzed repeatability and reproducibility.Tooling Fixture Design:Designed tooling fixtures (Bond Checker, Measuring Stands for Multi Lumen tubing) using Creo.Developed new test methods for the existing product line.Change Orders and Workflow:Created change orders workflow routings.Developed shadow documents to update/redline QC instructions.Incoming Inspections Support:Conducted Test Method Validations to support Incoming Inspections (Multi-lumen tubing, Connector Caps, Check-flow valves, etc.) from Incoming QC.