SUMMARY

• Dynamic and Experienced Project, Operations Management and Engineering Professional with demonstratedsuccess in engineering and manufacturing leadership specifically in the competencies of Neuro vascular / Cardiac ImplantableMedical Devices/Orthopedic/Surgical, NPI/NPD, Remediation.
• Extensive knowledge in Food and Drug Administration (FDA) regulations, 21 CFR, Part 11 (Electronic Records and Electronic Signatures), Part 210 (cGMP in manufacturing, processing, packaging and holding of goods), Part 211 (cGMP for Finished Pharmaceuticals), Part 810 (Medical Device Revise Authority), and Part 820 (Quality System Regulation).
• Excellent with Performance Test Design & Management.
• Experience in Process Improvement, Statistical Process Control and MINITAB.
• Implement solutions aligned with long - range goals, bottom line, feasibility, and ease of use, solving problems with innovation and cross-functional collaboration.
• Strong experience performing validation and verification activities of complex Enterprise System applications in the Medical device and Pharmaceutical Industries that include Oracle JD Edwards, Camstar MES, CMMS, Veeva Electronic Trial Master Vault, Learning Management System, WinNonLin, Packaging Serialization Track and Trace application etc.
• Performed Equipment Qualification, Packaging Qualification, Process Validation and Vendor & Material Qualification.
• Software Testing Life Cycle (STLC) experiences include Test Planning, Test Analysis, Test Design, Construction & Verification, Testing Cycles, Final Testing, Implementation and Post Implementation.
• Experienced in performing process qualification (PQ) activities including writing/reviewing of PQ reports and protocols in compliance with FDA guidelines, AQL standards, ISO regulations, and lean six sigma statistical standards for manufacturing, laboratory, and packaging equipment qualification.
• Working knowledge of GD&T.
• Hands on experience in reviewing and writing Test Method Validation (TMV)/Protocols for Equipment, and ancillary equipment/fixtures.
• Skilled in problem solving techniques involving Lean/Six Sigma statistical tools such as: DOE, ANOVA.
• Involved in activities related to the project using GAMP5, ISO 13485, FDA QSR, 21 CFR Part 11
• Extensive Device specific engineering and development, and manufacturing for Classes II & III, ISO 9001, ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management,Devices), 21 CFR 820 (FDA Devices, US), working familiarity with European Standards - Devices.
• Knowledge of Good Automated Manufacturing Practice (GAMP 5), FMEA and Six Sigma Implementation.
• Extensive experience in Process Development, Manufacture and Project Management of Neurovascular devices such:Guide Catheters, Micro Catheters, Sheaths, Guidewires and Stents; Cardiac Implantable Devices such: Pacemakersand its capacitor assembly.
• Project Management of all aspects of a manufacturing engineering package, to include: New products includingBOM's, ECO, CAD, Routers, Work Instructions, Procedures, Process Improvements, Tooling specifications,Product Design, Cost standards, Associate Training, Validation and Risk Management Documents.
• Knowledgeable in Risk Analysis and Health Hazard Evaluation as it relates to different device failure modes. Extensive experience in Quality Control, Root Cause Analysis, Process Validation and Packaging Validation, and Continuous Quality improvement.
• Experience in statistical analysis methods i.e. SPC/Six-sigma. Familiarity with various Root Cause Analysis tools i.e. DMAIC, 5 Whys, etc.
• Well versed with equipment ts and fixtures - Injection Molding, Laser welding.
• Well versed with review process documentation and validation per industry guidelines, and according to project task list; specifically, SOPs, MVPs, PSWs, FMEAs, DFMEAs, DVs, DVP, DOEs, Control Plans, and BOMs.
• Experienced in mitigating FDA 483 Warning Letters and correcting documentation for established medicaldevice manufacturers in the areas of Design History Files, remediation, Risk Analysis, and Design Verification andValidationactivities.
• Performed and maintained SysFMEA, DFMEA and Risk Assessment based upon use and misuse of device in accordance with IEC60601 3rd edition, IEC 60601-1-6 Usability Standard and ISO 14971 standards.
• Good oral and written communication skills with technical writing. Well versed with MS Office.

TECHNICAL SKILLS

Compliance: 21 CFR Part (11, 210, 211, 820, 56, 50), GAMP, cGMP, GxP (GDP, GMP, GLP, GCP), QSR, ICH Guidelines.

Business Tools: MS Office, Acrobat, MS VISIO, Share Point.

Computer System Validation: SOP’S, VMP, URS, FRS, DS, Test protocols and Summary Reports, RTM and VSR, Risk Assessment Techniques.

Methodologies: Software Development Life Cycle (SDLC), Validation Life cycle (VLC), Testing Life Cycle(TLC)

Other Tools: AutoCAD, Unigraphics NX, Teamcenter, Matlab, Maple, MS-Office, CAN Communication, Motohawk Tools, Technical Writing, Medical device Design control, GD&T, Tolerance Stack up analysis, Blue print reading

Medical Device Validation: CFR Part 820, QSR, ISO 13485

Validation Applications: UDI, MDM, LIMS, EDMS, AERS

PROFESSIONAL EXPERIENCE

Packaging Engineer

Confidential - Pleasanton, CA

Responsibilities:

• Responsible for providing project engineering support on the development of a centrifugal heart blood pump miniaturized for less invasive surgery & used as a bridge-to-transplant or long-term implant for patients with congestive heart failure.
• Involved in verification and validation of technical and functional design specifications.
• Providing technical lead support for implantable specific to LVAD pump hardware, including motor & PCBA assembly, hydraulic components, percutaneous driveline, blood cannulas, electrical feedthroughs, & graft connectors.
• Participated in test case proposal, test design documents and script reviews and base lined all in clear case.
• Conducted walkthrough’s and Test design reviews.
• Supported thevalidationof Standardized PackagingSystem(base off of SAP Enterprise Central Component (ECC), Environment, Health, and Safety) Category 4, which is configurable SAP software module, which supports all packaging activities including approved and marketed presentations along with new product package development.
• As a Test Analyst stood up delivery infrastructure using the agile SAFe framework and set up governance structure for check-ins and communication for the delivery sprint teams and leadership across the enterprise.
• Utilized six sigma methodologies for continuous improvements, corrective and preventive actions (CAPA)
• Performing engineering activities and documentation review for peer concept reviews, DIRs, & Project Plans (Biocompatibility Plan, Sterilization Plan, and Packaging Plan).
• Assisting with prototype preparation for bench testing (EMC/ESD/HALT), animal studies, & form-factor evaluation.
• Extensive 2D/3D CAD design experience, including expertise in Geometric Dimensioning and Tolerancing (GD&T) and design for manufacturability (DFM).
• Develop process improvement projects by gathering and analysing data.
• Extensive experience on Test Method Validation (TMV) for analytical, attribute and variable measurements.
• Used GD&T to interpret designs, blueprints and engineering drawings.
• Produced User Stories to be used throughout the project from estimation from basic design to final delivery.
• Responsible for writing Test cases to cover overall quality assurance using Test Director
• Making extensive visits to prospect suppliers and SJM affiliate companies engaging early capability assessments, prototype development runs, benchmarking and technology sharing.
• Successfully delivering concurrent engineeringguidancesuch asDesign Input, DFM, DFA, DFT,Supplier Selection, process validation/TMV/Protocols, Material Selection, Process Development, Standard Cost Assessments & NPI support.

Packaging Engineer

Confidential - Jacksonville, FL

Responsibilities:

• Accountable for Thoracic Market Portfolio including NPI revenue, project cadence and scheduleadherence. Key member of the Thoracic Portfolio Steering Committee.
• Worked on Process improvement activities to reduce the product related risk as well as the safety related improvements.
• Manage and lead a team of product development, marketing, regulatory, manufacturing, medical sales andtraining and quality cross-functional team members.
• Provide coaching and performance development for each of the cross- functional leads. Responsible for Resource Planning for entire Portfolio.
• Drove supplier development by assisting them in developing problem solving control tools such as: 8D, process mapping, FMEAs, mistake proofing, SPC, Process Capability/Cpk, GD&T, Gage R&R, etc.
• Used Agile Process for developing the application.
• Review legacy supporting documentation: TMVs, SOPs, MVPs, PSWs, FMEAs, DFMEAs, DVs, DVP, DOEs, Control Plans, and BOMs.
• Developed/Introduced multi-phased launch approach for new Sternal Closure Device.
• Focused on Speed to Market with CNC machined parts and Cost Improvement Phase utilizing injection molding.
• Provided quality-engineering support on the various phases of product development life cycle such as design verification, design transfer, process validation, design validation, product performance qualification (PPQ) and post-market review to mitigate the outstanding concerns.
• Applied quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, Cause & Effect Matrix, DOE and Control Plans.
• Represented the business requirements in various alternative views such as analysis models, process flow diagrams and user stories.
• Developed and implemented a quality plan and visual aids to establish acceptance criteria for a multiplicity injection molded component at incoming inspection of supplier parts.
• Validate several manufacturing processes and associated TMVs used to manufacture Catheters, occlusion, adhesive bonding, UV curing, flow, etc.).
• Member of cross functional team tasked to manage design changes to part/print, specifications, tooling, and associated risks.
• Support validation efforts and requirements for timely move/relocation of equipment and technology transfers, including the generation of TMVs, IQs, OQs, & PQs protocols, execution, and reports.
• Write, execute, and validate Test Methods and procedures for Variable and Attribute Data. Implement and release changes using Agile Documentation control.
• Led introduction / implementation of Lean NPD tools and techniques.

Validation/Quality Engineer

Confidential - Keene, NH

Responsibilities:

• Verification and Validation of Hypodermic Needle device manufacturing, and ancillary accessories. This Verification and Validation is for existing high speed automated assembly and test equipment. This equipment includes validation of on line occlusion test systems, and vision systems for inspection/verification for processes and devices.
• Re-execute Process Validation of several medical devices, including TMVs IQ, OQ, & PQ protocols and reports.
• Assured timely delivery of various documents User stories to the development team.
• Represented the business requirements in various alternative views such as analysis models, process flow diagrams and user stories.
• Establish documentation for Agile methodology for implementation with a very water-fall-centric development team.
• Review process documentation and validation per industry guidelines, and according to project task list; specifically, TMVs, SOPs, MVPs, PSWs, FMEAs, DFMEAs, DVs, DVP, DOEs, Control Plans, and BOMs.
• As part of testing, project had both Agile and waterfall Methodologies in place.
• Gap Analysis of current Validation Status and formulation of requirements to resolve findings.
• Revise/Update Risk Management Work Book (RMWB) to meet ISO and IEC standards.
• Test Method Validation (TMV) for Equipment, and ancillary equipment/fixtures.
• Write, execute, and validate Test Methods and procedures for Variable and Attribute Data.
• Merge and Implementation of new Quality System.
• Developed Design of Experiments (DOE) for Statistical Process Control and Design of Failure Mode and Analysis (FMEA) & System Risk Analysis.Evaluated & approved manufacturing design changes, process changes, procedures and specification changes.
• Implemented Process Management activities (PFMEA and control plans) within assigned client groups.Audited supplier validation documents for robustness as well as alignment with industry specifications.
• Developed Standard Operating Procedures (SOPs) based in the business requirements gathered for Validation Plan, Test Cases and Test Procedure. Documented the Test Scripts and analyzed them to check for compliance with 21 CFR Part 11 rules of FDA.
• Utilized statistical analysis andqualitytools - 5 Why's / DMAIC / Fishbone Diagram / Is-Is not.
• Performed Gauge R&R studies, process capability analysis and lead SPC implementation projects.
• Prepared a Validation Summary Report on the validation efforts. Performed GAP Analysis and also developed the corresponding Remediation Plan.
• Completed several equipment experiments and qualifications (IQ, OQ, PQ) to understand full functionality, efficiency, optimum operating conditions and internal documentation accuracy.
• Audited documentation, compiled data, and authored Process History Summaries, Process Validation Protocols andReports, and Annual Validation Reports.