Project Management Mechanical Design

ABHIMANYU INUMULA

ad5emp@r.postjobfree.com PH: +1-361-***-****

MANUFACTURING QUALITY COMPLIANCE VERIFICATION VALIDATION PROFESSIONAL SUMMARY

● Seasoned Manufacturing Quality Consultant proficient in advanced lean manufacturing, QC, EU MDR, Mechanical design, Six Sigma, Kaizen, Logistics, Procurement, Analysis, Quality and Project Management.

● Drafted, executed and reviewed validation protocols (IQ, OQ, PQ) for Qualification and the product life cycle development and management. Worked on New Product Introduction and Development (NPI, NPD).

● Assisted Design team with DFM, DFA, DFX, GR&R, MSA, Design analysis, Developing BOMs, releasing 3D and 2D Cad models for Agile PLM solutions, Product development and process validations to support Production.

● Performed Failure Mode and Effect Analysis (FMEA), Root Cause Analysis (RCA), Statistical Process Control

(SPC), Corrective Action and Preventive Action (CAPA), Non-Conformance Request (NCR).

● Experienced in documenting SPC, KPIs, Test Method Validation (TMV), Master Validation Plans (MVP), R&D, dry run, test scripts, test cases, Traceability Matrix (TM) and Validation Summary Reports (VSR).

● Hands on PLM system: ADAPTIV, WINDCHILL for any specification, drawings, records, reports, protocols, design validation, verifications, change controls and creation, modification, revisions under change requests.

● Strong knowledge on ISO 9001:2015, API-Q1 Quality Management Systems, ISO13485, ISO14971 and FDA part 21 CFR Part820, Part11, Part210, Part211 focused guidelines and regulations for medical devices.

● Performed SCR, CAPA, RCA, NCR Issues, supplier evaluation, contract manufacturers, product and design review, design analysis, Production management, Supply chain management, Risk Analysis, DMAIC, FMEA, PFMEA.

● Expertise in Verification and Validation activities along defect resolution with good working knowledge of GxP’s

(cGMP, GAMP, GLP and GCP), EU MDD/ MDR, GSPR, ICH guidelines and regulations.

● Responsible in Authorizing and reviewing Standard Operating Procedures (SOPs), Work Instructions (WI), Engineering Change Notice/ Order/ Request (ECN/ ECO/ ECR), SCR, SCAR in a cGMP and regulated facility.

● Possess excellent presentation, control charts, technical writing and verbal communication problem solving skills. TECHNICAL SKILLS

● Design Tools: CatiaV5, ANSYS, AutoCad, SolidWorks, Minitab, JMP, CNC machining, coding, lathe, milling, Creo2.0.

● Lean Six Sigma Tools: DOE, 5S, Kaizen, DMAIC, DMADV, DFMEA, FMEA, PFMEA, RCA tools, PPAP, APQP.

● Regulations: EUDAMED, EU MDR, GSPR, FDA 21 CFR Part 820, Part 11, Part 210, ISO 9001:13485, 14971.

● Project Tools: ADAPTIV, WINDCHILL, ETQ, SAP, Appian, ATMS, Visio, MS Office, SharePoint, Teams, JIRA.

● Certifications: SixSigma Green belt, PMP, CSWA (SolidWorks), In-plant Training with CITD/CAD-CAM. PROFESSIONAL EXPERIENCE

Johnson & Johnson MedTech (CSS), CA Apr 2023 – Present Role: ME QA-EU MDR –Consultant

EU MDR Assessments, RS screening and mapping, Technical Writing, BOMs, NPI/ NPD, SCIP, CAPAs, NB-R Responsibilities:

● Established SME for R&D, Quality Assurance, BOMs, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to develop innovative new products for the cardio/ neurovascular medical device industry.

● Author/ review/ approval of EU MDR Supplier QA documentation, risk and impact assessments, Product Stewardship

(PS) generating procedures, governance council documents, using PLM system adhering Quality standards.

● RS screening for New Product Introduction/ Development (NPI/ NPD) and existing products within the portfolio, updating BOM subcomponent and sub-tier level along with SDS, supplier declarations, materials information.

● Collect and update SCIP data from RS tools, organize spreadsheets for EU RoHS, REACH SVHC substances. Gather information from ECHA website to categorize and publish in Article 33 data for J&J MedTech (CSS) devices.

● Document Change Controls, Deviations, CAPA findings, Investigations, and review of Quality effectiveness check, periodic reviews, SCAR, TMV scripts, Validation documents, BioTox comp and packaging reports.

● Expertise in assessments by reviewing DFMEA, PFMEA, CTQ, CQA, Design for assembly (DFA), DHRs, DMRs, Product validation files for MDR submission for Initial stages of NPI/ NPD products, GR&R, and DOEs.

● Gathering supplier declarations for EU MDR, CA prop 65, EU REACH and other applicable environmental regulations for BWI/ CNV Catheters, Implants: Breast, Heart, Aneurysm clearing microcoils, Saddles and sub-assys.

● Addressed notified body questions from audits as per Product stewardship (PS) compliance with regulatory on GSPR 10.1 and worked closely with R&D, Quality and Regulatory to meet the Notified body approval expectations. Johnson & Johnson MedTech, CA Aug 2021 – Mar 2023

Role: Manufacturing Engineer– Consultant

Change Controls,SCR, Risk Assessments,Validations, IQ/ OQ/ PQ, Fixtures, Technical Writing, BOMs, NPI/ NPD, CAPA Responsibilities:

● Lead projects in Manufacturing Engineering (ME) & Product life cycle Management (LCM) teams related to product design, production changes, supplier changes, and executing protocols to meet client and regulatory requirements.

● Established SME for R&D, Quality Assurance, BOMs, Supplier Quality, Planning, Purchasing, Regulatory, and Manufacturing to develop innovative new products for the cardio/ neurovascular medical device industry.

● Document Change Controls, Deviations, CAPA findings, Investigations, and review of Quality effectiveness check, periodic reviews, SCAR, TMV scripts, IQ/ OQ/ PQ Validation documents, packaging and sterilization reports.

● Expertise in assessments by reviewing DFMEA, PFMEA, CTQ, CQA, Design for assembly (DFA), DHRs, DMRs, Product validation files for R&D testing for Initial stages of NPI/ NPD products, GR&R, and DOEs.

● Worked on generating new BOMS for various catheters by using regression, correlation techniques, leveraging DFM, DFA for parts from legacy catheter parts/assemblies to reduce manufacturing cost for NPI/ NPD products.

● Key role in working cross functional with R&D and Sustainable teams for manufacturing of disposable instruments, complex components. Assist Supply chain team on procures new manufacturing tooling, fixtures and equipment.

● Supported the team to modify tooling fixtures and designs for the R & D department and set tolerance points for various optical, navigational, bidirectional, revascularization catheters, Micro catheters and large bore catheters.

● Proficient in periodic review projects to maintain, monitor, calibrate and modify the specs, drawings as required for cost effectiveness. CAPAs for Shelf-life monitoring, NCs for multiple causes and product dispositions.

● Worked on commissioning and qualification for manufacturing equipment in clean rooms, compressed air modules, gas monitoring systems, DI water, liquid nitrogen supply systems, Insulators, valves, airflow visualization.

● Performed Periodic Reviews, Tooling calibrations, MSA, Gage R&R testing, ANOVA, accurately based on the CP, CPk values to set the sampling and hands on Geometric Dimensional Tolerances (GD&T) with quality check.

● Verified and performed SPC, PPAP, Six Sigma methodologies, for NPI/ NPD to improvise product quality and mitigate risk to support product lifecycle management, NCRs, SCR, SCAR and other supplier evaluations.

● Assisted in manufacturing lines for Pulserider detachment systems, sub-assemblies, catheters, microcoils, Knight rider kits, sealer machines, packaging equipment, inspection fixtures, winding fixtures, welding fixtures.

● Performed & conducted packaging material testing, packaging process validation, sterilization process validation, sterilization testing to develop and execute Packaging & sterilization validations (IQ/OQ/PQ).

● Worked with Appian tool to handle SCRs, ATMS to support Audits, ETQ system to handle CAPAs, NCs, NCRs.

● Lead projects in Manufacturing Engineering (ME) & Product life cycle Management (LCM) teams related to validations, product design, production changes, supplier changes, Periodic review Projects and validate it by performing shelf life determination, aging studies, Biocompatibility testing, packaging integrity testing, sterilization testing, dose mapping testing and design compatibility.

● Lead a team of ME on performing the Periodic reviews and calibrations for the tooling and fixtures in the cleanroom.

● Lead projects for Validations(IQ/OQ/PQ) for equipment qualifications, and SCRs for production increase along with process, product related changes.

● Developed and executed validation protocols (IQ/OQ/PQ) for packaging equipment, including catheters, subassemblies and detachment system, ensuring equipment performance and integrity. Conducted packaging material testing (e.g., material compatibility, shelf-life studies). Performing packaging process validation (e.g., sealing, sterilization). Conducted risk assessments and implemented risk mitigation strategies to address potential packaging-related hazards and quality risks.

● Developed and executed sterilization validation protocols and reports (e.g., EO, gamma, steam). Conducted sterilization process validation (e.g., cycle verification, dosing verification), Performed sterilization testing (e.g., biological indicators, sterilization verification). Collaborating with sterilization service providers and internal teams to ensure compliance and effectiveness, Implemented and maintained Packaging & sterilization validation files and records

Windlass Engineers & Services, Inc., TX Jan2018 – Aug 2021 Role: Design & Quality Engineer

Design, Quality, APQP, PPAP, NPI/ NPD, Equipment/ Instrumentation Testing, NC,CAPAs, Technical Writing, BOMs. Responsibilities:

● Established SME for R&D, Quality, BOMs, Supplier Quality, Planning, Procurement, Regulatory, & Manufacturing to develop innovative new products for Oil & Gas industry to comply with API Q1 and ISO 9001:2015 standard QMS.

● Document Change Controls, Deviations, CAPA findings, Investigations, and review of Quality effectiveness check, periodic reviews, SCAR, TMV scripts for equipment Validation, packaging and sterilization reports.

● Expertise in assessments by reviewing & Performing DFMEA, PFMEA, CTQ, CQA, Design for assembly (DFA), DHRs, DMRs, Product validation files for R&D testing for Initial stages of NPI/ NPD products, GR&R, and DOEs.

● Performed Quality control checks, FAI, FAT, DOE, Weldment penetration tests (PT), Magnetic particle testing (MPT), Pressure tests, Vacuum seal tests, Hydrostatic, Pneumatic, High-pressure testing for Oil & Gas equipment.

● Worked on APQP, PPAP methodologies with product lifecycle and process development, Implementation, review and review. Innovate and custom design equipment projects with the production teams both in India and US.

● Generated new BOMS, Designs for HP test units, BOP control units, Pup joints by using regression, correlation techniques, leveraging DFM, DFA for parts from legacy parts/assemblies as per CIP for NPI/ NPD products.

● Key role in working cross functional with R&D and Sustainable teams for manufacturing of disposable instruments, complex components. Assist Supply chain team on procures new manufacturing tooling, fixtures and equipment.

● Collaborated with the tooling & Production team on mold design, Periodic Review, conducted necessary validations for equipment, Design modifications for Sustainable Manufacturing & assembly with Solid works simulations.

● Proficient knowledge on castings, moldings, forgings, pipes, and other required parts for all the manufacturing processes and knowledge on API Q1, API 6A,16A, 16F, 20A, 20B, 20C and NACE configurations.

● Responsible for making a $2 million worth project equipment design by start-to-end process over 200+ Oil & Gas equipment prototypes for customers like Honeywell, NOV, Varec, Cameron, Atlas, Schlumberger, Pufferswiven.

● Worked on materials commonly used in piping construction, including carbon steel, stainless steel, and exotic alloys, and can recommend appropriate materials based on factors such as fluid composition, temperature, and pressure. Performed stress analysis and sizing of piping systems to ensure compliance with regulatory requirements and operational safety standards

● Proficient in creating and interpreting PFDs and P&IDs, which serve as the blueprint for the layout of piping networks and the integration of instrumentation such as valves, pumps, meters, and control systems

● Knowledge on instrumentation devices, including pressure, temperature, level, and flow sensors, and have experience integrating these devices into control systems for process monitoring and automation. Had experience designing and implementing SIS solutions to mitigate process safety risks and ensure compliance with industry standards such as IEC 61511 and ISA S84.

● Developed and executed validation protocols (IQ/OQ/PQ) for packaging equipment. Conducted packaging material testing (e.g., material compatibility, shelf-life studies). Performing packaging process validation (e.g., sealing, sterilization). Conducted risk assessments and implemented risk mitigation strategies to address potential packaging-related hazards and quality risks..

Viant Medical( Solware IT Technologies LLC) Jan 2017 – Jan 2018 Role: Validation Engineer/Product Analyst –Consultant Change Controls,SCR, Risk Assessments,Validations, IQ/ OQ/ PQ, Fixtures, Technical Writing, BOMs, NPI/ NPD, CAPA Responsibilities:

● Author, review and approve technical instrumentation validation documentation such as IQ/OQ/PQ, Validation Master plan (VMP), Risk Assessments (RA), Traceability Matrix (TM), and Validation Summary Reports (VSR).

● Responsible for the Design analysis, review of Design history files (DHF), Device master record (DMR), Device history record (DHR), DOE, Six Sigma Methodologies - DMAIC, DMADV, RCA, FMEA, Process mapping & SPC.

● Worked on conducting Hoop Stress to identify most and least complex balloon structures, statistical data analysis, MSA, GD&T, Gage R&R testing, ANOVA to obtain the best outcome for validation and qualification results.

● Providing guidelines and support to inspectors on measuring a feature of implants, case, instruments using, calipers, micrometer, Go-No-Go Gauges, comparator, Injection Molding Machines, and other cGMP compliant devices.

● Executed scripts/ protocols DFMEA, PFMEA, CTQ, CQA, Design for assembly (DFA), DHRs, DMRs, Product validation files for R&D testing for Initial stages of NPI/ NPD products, GR&R, and DOEs along Summary reports.

● Cost reduction using lean Six sigma tools, performing validations, generating non-conformance and summary reports, maintaining records complying with the QMS based on ISO13485, ISO14971, FDA 21 CFR Part 820, Part 211.

● Worked on assembly line for balloon bond, tipseal, taper, transition bond, conversion & luer born. Performed balloon leak tests for catheters to support R&D on NP development for DOE, PPAP, Part-to-Part & Lot-To-Lot performance.

● Worked on commissioning & qualification for manufacturing equipment in clean rooms, AHUs, gas monitoring systems, compressed air, liquid nitrogen supply systems, Insulators, valves, to perform airflow visualization study.

● Performed Risk analysis, CAPA, Performed Root cause analysis (RCA) with 5 whys, fishbone diagrams, DFMEA, UFMEA, Internal Audits, Management reviews.

BMT Medical Devices, India Jun 2014 – Jul 2015

Role: Asst. QC and Assurance Engineer –Consultant

SCR, Risk Assessments, FAT, FAI, Technical Writing, BOMs, Supplier qualification, NCR, SCAR, CAPAs. Responsibilities:

● Studied and revised documents, procedures, processes related to FDA21 CFR part 820 regulations and helped senior QC on writing, maintaining records complying with ISO9001, ISO13485 and QMS manual.

● Performed CAPA, Internal audits, contract reviews, process validation and manufacturing risks mitigations using lean six sigma tools to improve efficiency. Maintained records, documents and to meet regulations and client requirements.

● Implemented GD&T process on design verifications, calculations, analytics with reference to the regulatory standard and implemented them to improve the process risk mitigation.

● Learned and Performed risk analysis and other tools like FMEA, Six Sigma, Kaizen principles, control charts, flowcharts, RCA, PPAP etc. Involved in supplier qualification, AVL/ASL list generation, supply chain management. Shalivahana Green Energy LTD, India Jan 2014 – Jun 2014 Role: Intern Trainee ( ME Quality Assurance Engineer) Repairs, Breakdowns, Machining, Quality, Testings, Technical Writing, BOMs, NCR, CAPAs. Responsibilities:

● Attended the repairs and breakdowns, Turbine, boilers, and cooling towers maintenance with the Company guidelines. Studied controlling the power-generating equipment which uses fuel as coal, nuclear fuel, natural gas, and bio-waste.

● Pneumatic, hydraulic, Electro-mechanical functional equipment maintenance, Installation, repair, fabrication, tool room inventory, plumbing, piping, electric and mechanical machinery maintenance, Assist on NC and CAPA.

● Worked on APQP, PPAP methodologies with product lifecycle and process development, Implementation, review and review. Worked on innovative custom design equipment projects to configure with the production and R&D teams.

● Assisted in design & manufacturing of valves, fittings and tooling fixtures required for the machining using CNC & lathe machining processes for making the operations successful in obtaining the required object as per Specifications.

● Reading the charts and gauges to monitor voltages and electricity flows and adjusting the controls to regulate the power flows. Checking the Equipment and indicators to detect evidence of operation problems. EDUCATION

● Master of Industrial Management Texas A&M University-Kingsville. May 2017

● Bachelor of Mechanical Engineering SriIndu College of Engineering & Technology May 2014

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