- 5+ years of experience in Test Method Validation (TMV), Process Validations, DHF remediation, and CAPA.
- Experienced in TMV including attribute and variable methods using Gage R&R analysis.
- Worked with R&D team during D&D, V&V phase of a new product and developing a new test method for testing.
- Experienced in developing manufacturing processes for medicalcomponents manufacturing.
- Reviewed and documented DHF files including Design and Development plan, Design Input, Design Output, Design transfer, Verification & Validation plan, and Risk Management.
- Worked on DHF Remediation of medical devices and updating PFMEA, routers, BOM, and SOPs.
- Experience in Investigating and resolving work - in-process problems by using root cause analysis.
- Assisted development engineers in designing and creating fixtures.
- Experienced in writing Protocols, Final reports, rationales and other documents.
- Initiated CAPA and Remediation Activities for different types of medical device documents.
- Experienced in carrying out problem solving techniques including Lean/Six Sigma statistical tools as Minitab.
- Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, and SPC analysis.
- Experience of Production Part Approval Process (PPAP) and Advanced product quality planning (APQP).
- Strong analytical and problem solving skills and ability to work independently or with cross functional teams.
- Experience in Computer Aided Design (CAD) and Additive Manufacturing (3D Printing, Selective Laser Melting).
- Hand on experience in SolidWorks, CREO, Pro-E, ANSYS, STAR-CCM+, HyperMesh, and AutoCAD.
- Understanding ofmedicaldevice (21CFR 820 & ISO13485) regulatory standards and engineering applications.
- Knowledge of ISO, ASTM Standards and GD&T Techniques.
- Experience with medical device compliance requirements based on FDA Quality Systems Regulations.
- Proficient in MS Excel and other MS office tools.
Technical Skills: TMV and IQ/OQ/PQ Validations, Lean/Six Sigma, DFMEA, PFMEA, Root Cause Analysis, DHF remediation, Corrective Action and Preventive Action (CAPA).
Designing Skills: SolidWorks, CREO, Pro-E, ANSYS, STAR-CCM+, HyperMesh, AutoCAD
Data Analysis Tools: Excel, Minitab
- Experience in validation Installation/Operation/Performance Qualifications (IQ/OQ/PQ) for equipment used in manufacturing of medical devices.
- Prepared multiple test protocols and experienced defining the test parameters for DOE.
- Created protocol and summary report of Test Method Validation (TMV) for various inspecting methods.
- Analyzed the collected data using statistical tools as Minitab.
- Developed mechanical test and validation documentation of new and existing products.
- Experience in Failure Mode Effects Analysis (FMEA), Risk Analysis, and Master Validation Plan (MVP).
- Coordinate efforts during investigations, validation deviations, and CAPAs.
- Participated in CAPA meetings and activities, helped to identify the root causes of the manufacturing problems.
- Conducting weekly design reviews with the manufacturing and the cross-functional teams solving gaps in the remediated documents relevant to specific Design History Files (DHF).
- Work with cross functional teams to develop implementation strategies to create the DHF for the medical devices.
- Perform searches, generate reports, and analyzecontrol charts and datatrendsusing Minitab, TipQA and Enovia forNon Conformance Report (NCR) systems.
- Developed and maintained Requirement Traceability Matrix (RTM).
- Researched and developed DFMEA and risk analysis documents for medical devices.
- Experience with root cause analysis and some risk assessment tools (DMAIC, fishbone) via investigative work.
- Regular interaction in overseeing manufacturing processes,, inspections and continuous improvement projects.
- Helped to develop the tests to validate the device, and performed experimental design by testing with non-fielded products while designing test systems.
- Worked with Product Development team to develop sterilization validation and /or biocompatibility protocols and ensure reports are documented accurately.
- Develop adequate sampling plans, inspection procedures, and test methods to maintain product performance and meet long term manufacturing goals (yield/scrap, acceptance sampling, etc.).
- Develop and maintain new products validation plans based upon internal and client SOPs.
- Worked with the other engineers on process improvement projects to enhance and maintain high standards.
- Assisted R&D engineers to support implementation of new products by reviewing quality and validation plans.
- Using six sigma principals identified key process indicators and developed dashboards to illustrate the KPIs.
- Maintained positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performed Statistical Analysis such as tolerance intervals, process capability and DOE.
- Conducted and reviewed Installation Qualifications (IQ) and Operational Qualifications (OQ).
- Developed IQ/PQ protocols and IQ/PQ reports.
- Developed and executed process validation protocols, attribute and variable Test Method Validation (TMV).
- Repeatability and Reproducibility (R&R) studies on methods were used for testing medical products.
- Involved in designing test fixtures for performing Test Method Validation on medical devices.
- Involved in performing Gap Analysis and preparing the Remediation plan.
- Remediation Activities including writing Validation Plans, Risk assessment, DOE, Process Validation, Test Method Validation, assisting with s protocols and writing validation summary reports.
- Worked with Validation engineers for all functional and interface test methods for medical devices.
- Performed DFMEA and PFMEA analysis and updated required documents.
- Assisted engineers in CAPA and existing RM Plans and suggested Remediation activities.
- Identified the potential Hazards in the device and addressed them in the Risk Management Plan.
- Created work instructions for the operators and updated existing operating procedures.
- Conducted product testing, creates models, and prototypes, and provided feedback to design engineers.
- Participated in improvements activities and applying lean and six sigma methodologies.
- Led all continuous improvement techniques including: Lean Manufacturing Principles, S.P.C., and Kaizen Blitz events, which resulted in increase in the throughput, decrease in labor costs, and improved safety.
- Monitored, measured and reported manufacturing performance and developed new techniques to reduce losses and improve quality.
- Recommended and implemented changes to product or process which would improve cost, delivery, and quality for the customer.