Medical Devices Device

Mahidhar Karthik Tanga Email: ********************@*****.*** Mobile: 502-***-****

Summary

8+ years of experience in Validation, Manufacturing, Test Method Validation (TMV), Process Validations, DI-IF remediation, and CAPA in pharmaceutical, biotech, or medical devices industries

Validation Engineer with strong experience in PI System (Aveva PI) validation, specializing in Computer System Validation (CSV) within regulated pharmaceutical environments. Skilled in applying SDLC and GAMP 5 principles to ensure compliance with 21 CFR Part 11 and data integrity standards.

Experienced in TMV, including attribute and variable methods using Gage R&R analysis.

Worked with the R&D team during D&D, V&V phases of a new product and developed a new test method for testing.

Experienced in developing manufacturing processes for medical component manufacturing.

Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, and SPC analysis.

Experience in 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.

Leading CSV efforts for critical systems including Aveva PI, aligning with FDA and internal compliance standards.

Experience in Computer Aided Design (CAD) and Additive Manufacturing (3D Printing, Selective Laser Melting).

Experience with medical device compliance requirements based on FDA Quality Systems Regulations.

Proficient in MS Excel and other MS Office tools.

Hands-on experience in SolidWorks, CREO, Pro-E, ANSYS, STAR-CCM+, HyperMesh, and AutoCAD.

Reviewed and documented DI-IF 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-progress 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.

Understanding of medical device (21CFR 820 & ISO13485) regulatory standards and engineering applications.

Technical skills

Skills: TMV and IQ/OQ/PQ Validation Protocols, Lean/Six Sigma, DFMEA, PFMEA, Root Cause Analysis, Remediation, RTM, Risk Assessments, Corrective Action and Preventive Action (CAPA).

Designing Skills: SolidWorks, CREO, Pro-E, ANSYS, STAR–CCM+, HyperMesh, AutoCAD.

Data Analysis Tools: MS Office (Excel, Word, PowerPoint), ERP systems (SAP/Oracle), and CAD tools, and Minitab.

Automation: SCADA, Aveva PI, PLC, BMS, DeltaV.

Cleaning Validation: Experience in establishing cleaning validation strategies, performing risk assessments, defining residue limits, and analyzing validation data for medical devices.

Regulatory Compliance: Strong understanding of medical device regulations, including FDA, ISO 13485, GMP, 21 CFR Part 11, EU Annex 11, ALCOA+, and audit preparedness.

Technical Documentation: Adept at creating and maintaining controlled documents such as procedures, technical drawings, BOMs, and routers.

Manufacturing Process Engineering: Hands-on experience with machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding processes.

Project Management: Capable of leading cross-functional project teams, creating project schedules, and delivering results within deadlines.

Equipment Validation: Autoclaves, Incubators, Skids, Process Tanks, CIP Tanks, Bioreactors, Refrigerators, Freezers, Kaye Validator (2000 and AVS).

Professional Experience

Manufacturing Engineer

Pfizer, Rocky Mount, NC Jun 2023 - Present

Responsibilities:

Experience in validation Installation/Operation/Performance Qualifications (IQ/OQ/PQ) for equipment used in the manufacturing of medical devices.

Developed and executed cleaning validation protocols (IQ, OQ, PQ) for medical devices in compliance with FDA 21 CFR 820 and ISO 13485 and executed testing activities using Kneat, following ALCOA+ and data integrity standards.

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 DI-IF for the medical devices.

Prepared multiple test protocols and was experienced in defining the test parameters for DOE.

Created protocol and summary report of Test Method Validation (TMV) for various inspecting methods.

Supported and optimized manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding.

Utilized ERP systems and CAD tools to manage product data and support engineering change controls.

Conducted cleaning risk assessments and established residue limits to ensure product safety and regulatory compliance.

Analyzed the collected data using statistical tools as Minitab.

Developed mechanical test and validation documentation of new and existing products.

Experience in Failure Mode and Effects Analysis (FMEA), Risk Analysis, and Master Validation Plan (MVP).

Coordinate efforts during investigations, validation deviations, and CAPAs.

Perform searches, generate reports, and analyze control charts and data trends using Minitab, TipQA.

Process/Quality Engineer

Gilead, CA Sep 2020 – Dec 2022

Responsibilities:

Performed Statistical Analysis such as tolerance intervals, process capability, and DOE.

Remediation Activities, including writing Validation Plans, Risk assessment, DOE, Process Validation, Test Method Validation, assisting with protocols, and writing validation summary reports.

Worked with Validation engineers for all functional and interface test methods for medical devices.

Collaborated cross-functionally with Quality Assurance, Manufacturing, and Engineering teams to implement effective cleaning and manufacturing strategies.

Performed DFMEA and PFMEA analysis and updated required documents.

Analyzed validation data to identify process trends, support CAPA investigations, and drive continuous improvement.

Applied Lean and Six Sigma methodologies to optimize process efficiency and reduce variability in critical manufacturing operations.

Executed equipment qualifications and process validations to support production readiness and quality assurance.

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.

Led feasibility studies to evaluate process capability, capital equipment requirements, and cost estimation for new product introductions.

Involved in designing test fixtures for performing Test Method Validation on medical devices.

Involved in performing Gap Analysis and preparing the Remediation plan.

Manufacturing Engineer

Seagen, WA Aug 2018- Apr 2020

Responsibilities:

Developed and maintained Requirement Traceability Matrix (RTM).

Researched and developed DFMEA and risk analysis documents for medical devices.

Worked with the 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 product validation plans based upon internal and client SOPs.

Worked with the other engineers on process improvement projects to enhance and maintain high standards.

Experience with root cause analysis and some risk assessment tools (DMAIC, fishbone) via investigative work.

Developed and tracked project plans, ensuring timely execution of validation and manufacturing process improvements.

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.

Maintained positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Assisted R&D engineers to support the implementation of new products by reviewing quality and validation plans.

Developed and executed validation documents (URS, IQ, OQ, PQ) for PI System in accordance with GAMP 5 and regulatory guidelines.

Ensured 21 CFR Part 11 compliance by validating audit trails, user access, and electronic data handling in PI.

Collaborated with cross-functional teams to implement, test, and document PI Interfaces and Asset Framework (AF) configurations.

Process/Quality Engineer

Bharath Biotech, Hyd, IND Nov 2015 – Dec 2017

Responsibilities:

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.

Assisted engineers in CAPA and existing RM Plans and suggested Remediation activities.

Monitored, measured, and reported manufacturing performance and developed new techniques to reduce losses and improve quality.

Enhanced the process control for the FE & final assemblies by adding visual SPC process control tools.

Created and maintained controlled technical documentation such as process procedures, drawings, BOMs, and routers.

Prepared for and participated in internal and external audits by ensuring validation documentation met regulatory requirements.

Supported converting manual production travelers (assembly, R&R instructions) to the E-MES platform.

Recommended and implemented changes to product or process that would improve cost, delivery, and quality for the customer.

Conducted product testing, created models and prototypes, and provided feedback to design engineers.

Participated in improvement activities and applied lean and six sigma methodologies.

Led all continuous improvement techniques, including Lean Manufacturing Principles, S.P.C., and Kaizen Blitz events, which resulted in an increase in the throughput, a decrease in labour costs, and improved safety.

Education

Bachelor’s, Major Mechanical Engineering, Lovely Professional University, 2015, India.

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