Engineer Quality

Anand Rangoli 603-***-****

Chelmsford MA-***** ********@*****.***

Professional Summary

10+ years of experience in Medical Device, Project Engineering, Quality Engineer, Polymer Processing, Molding/Compounding.

Hands on experience in plastic testing equipment using ASTM/ISO standards, ISO13485, FDA related projects. Experienced in polymer material selection and troubleshooting in plastic equipments.

Experience in design techniques for plastic parts and tooling involved in the design and production of plastic parts.

Coordinate projects with various customers which involve NPD, R&D, Manufacturing, Quality & Production scale-up in CGMP, clean room environment.

Proficient in Solid-Works, AutoCAD, Flow 2000i, Mold flow, SQL Microsoft Word, Access, Excel, Project Management (Gantt Charts).

Hands on experience on material characterization equipment to measure melt viscosity, DSC, TGA, GPC, FTIR, mechanical properties and UL test.

Six Sigma Greenbelt certified and used analytical tools like DFMEA, PFMEA, CpK studies, Control Plan, Validation, PPAP for completion of the projects.

Relevant Experience

Experience in managing and coordinating Design Control Projects from inception to completion for automotive/aerospace/medical device companies.

Perform statistical analysis and experience in writing validation protocols and reports (IQ/OQ/PQ).

Build and maintain lab operation in Molding, Extrusion, Blending & Testing for plastics industry.

Support Product and Application development for Flame Retardant polymers.

Work History

NN.INC (microPEP) SEPT 2015 - PRESENT

Project Engineer /Quality Engineer

Quote new engineering projects including tooling and piece pricing

Identify requirements for proposed project including secondary operations and testing requirements

Set and meet project milestones from design stage to production hand off

Evaluate materials and develop processes to manufacture materials for use in products that must meet specialized design and performance specifications

Perform mold flow analysis on 3D CAD model to optimize client submitted designs for optimal designs to fill mold cavity with molten plastic

Execute IQ/OQ/PQ validation protocols for medical devices

Support production floor in identifying root cause and corrective action implementation of production by running DOE’s studies, Gage R & R, gate seal off and material viscosity studies.

Organize documentation such as process flow diagrams and PFMEA for PPAP submittal

Review customer designs and tolerances to determine manufacturability

Part of APQP project management tools, advise management of any cost related issues for assigned projects and make recommendations to optimize mold/part design as required.

Review proposed tool designs from outside sources to determine suitability

Helix Medical Jan 2015 - June 2015

Quality Engineer/Project Engineer (CONTRACT)

Provide support to manufacturing engineering on NPD products for equipment and process validation protocols and reports (IQ/OQ/PQ).

Internal and External Audit for NPD activities to ensure compliance with Helix Medical Quality System policies, procedures, standards (FDA, ISO 13485 and other worldwide regulatory agencies), and other applicable standards pertaining to medical devices; offer recommendations for continuous improvement.

Represent Quality in NPD design reviews, stage-gate reviews, and design transfer to production.

Provide quality engineering support and approval of test method validations, Verification and Validation strategies, activities, protocols, reports.

Cross functional team participation, representing Quality Engineering, on New Product Development (NPD) projects and products.

Support launch of new products, lead the Design Control Quality meeting and review quality aspects.

Support daily production, lead CAPA meetings and meet Customer Satisfaction Quality Aspects.

HAEMONETICS CORPORATION DEC 2012 - DEC 2014

Quality Engineer/Project Engineer (CONTRACT)

Haemonetics has a comprehensive portfolio of devices, information management, and consulting services offers blood management solutions for each facet of the blood supply chain from plasma and blood collectors to hospitals.

Lead independent Design Control Projects Quality Audits, internal audits and technical support projects coordinate portions of larger projects.

Lead design reviews at the sub-system level working towards an interdepartmental consensus.

Manage the Corrective and Preventive Action (CAPA) system, Ensure all projects is compliant to QMS through SOP updates and training.

Expertise using design control Agile software to document engineering work from concept to release.

Write complex test protocols; review and reject or approve test protocols developed by others, documents/reports findings, and provides corrective guidance.

Execute process mapping & DOE, Risk Analysis, FMEA studies on disposable components: Ultrasonic Welding, Hot plate sealing. Assist in setting up manufacturing equipment and define processes for assembly of multicomponent plastic disposable.

Perform and document IQ, OQ, and PQ of multicomponent plastic disposable assembly.

Execute disposable package design challenge testing and document investigational studies.

Utilize Solid Works and AutoCAD to update and release drawings and specifications. Experience with testing of medical devices involving Tensile Testing, pump efficiency tests, leak test used in medical industry.

Identify product and process improvement, lead and support their implementation.

Knowledge of MDD, IVDD, FDA, ISO 13485, 21CFR820, QSR regulations.

FRX POLYMERS SEPT 2010 - NOV 2012

Plastics Processing Specialist(CONTRACT)

FRX Flame Retardant Polymers are fully transparent, high flowing and, due to their high phosphorus content, are inherently flame retardant. Non- Halogenated material with extreme FR properties.

Work with professionals, marketing personnel and business consultants to plan and execute daily operations in the laboratory.

Understand and maintain capabilities in processing and characterizing polymers and oligomers. record and organize data/results.

Work directly with vendors to order polymer raw materials and to schedule timing and priority of Injection and Extrusion runs.

Maintain an updated production schedule for Extrusion, Injection Molding & Testing Equipment.

Perform analytical testing on all master batch runs to develop CoA for customers.

Minimize downtime and improve work output efficiency

Develop and implement methods to improve masterbatch processing

Develop improved processing techniques, run experiments to prove concepts using DOE.

Identify processing aides and additives for Discoloration and Dispersion

ECM PLASTICS JUNE 2009 - MAY 2010

Process Engineer(CONTRACT)

Train ALL production personnel in the correct use of feeders.

Create Training Matrix that includes retraining and measure of training effectiveness.

Support the Production Department with any\all Feeder issues.

Assist Extruder Operators with Compounds that require multiple feeders.

Create solid documentation to support consistent feeder set-up per Color #.

Evaluate the accuracy of problematic compounds, by auditing the process and evaluate the accuracy of the data, and keep a log.

Continue to input accurate processing data into the AS400.

Plan and Conduct Trials/Projects in R&D for FEP, Engineering plastics, Production, scale-up compounding runs from Development to Production size.

Active Member of ISO Corrective Action Review Board.

AGION TECHNOLOGIES MAR 2007-AUG 2008

Polymer Process Engineer(CONTRACT)

Perform preventative maintenance and general up-keep on the extruder, injection mold, and other processing and supporting equipment.

Perform all compounding runs for internal and external customers.

Order all polymer raw materials for runs – resins, additives, etc.

Perform analytical testing on all master batch runs

Initial and final moisture analysis, AM powder content by ASH analysis

Post-handling of all processed master batch for internal and external customers

PUTNAM PLASTICS OCT 2008 – FEB 2009

Manufacturing Engineer(CONTRACT)

Processing and understanding of Material (TPU, TPE, PE, PP, Pebax, PVC, Polyamides) behavior through dies and tip profiles.

Performing Rheology tests using Capillary Rheometer and Melt Flow Index for the incoming materials and using that data in Extrusion.

Helped assist in the development of Extrusion Simulation Software for medical devices using CFDesign using Solid Works for various tips and dies for extrusion

Designed extrusion dies and tips for different Multi-lumen tubes using Solid Works

Assist in Clean room for medical tubing with testing using Instron tensile and burst to test

Preparing documentation of manufacturing practices and drafting work instructions.

GATES MECTROL JAN 2006 - NOV 2006

Process Engineer(OPT)

Procure materials needed to construct prototypes and supervises the design engineering of new models.

Plans and develops test programs for prototypes, including prototype equipment.

Analyzes test data and reports to determine if designs meet functional and performance specifications.

Analyzes, evaluates, sources, and coordinates the procurement of new materials to support model changes.

Analyzes evaluate and recommend cost improvement ideas through product, vendor, and design changes.

Provides support to sales and marketing on product presentations and customer support.

ATRIUM MEDICAL JUNE 2005 - DEC 2005

Process/Quality Analyst(OPT)

Provide Process Design Engineering to R&D, Manufacturing and Product Development in catheter assembly area, specialization in working with various sizes of balloons.

Provides input to new equipment designs with an emphasis on concurrent engineering and improved productivity techniques, helped in introducing the Extrusion line for belts, tubing for PET, PEBAX, 75%Hytrel/25%PET, Nylon, HDPE, Peek etc.

Assists with applying statistical analysis techniques.

Assists with R&D protocols for new product introduction.

Participates in new equipment qualification and validation with protocols for IQ/OQ/PQ for the new extrusion system.

TDC MEDICAL MAR 2004 – OCT 2004

Process Engineer (Summer Internship)

Set up the layout for Extrusion line from scratch for medical tubing, especially used for Catheters, Balloons, Stents, hypo-tubes.

Experience with Balloon blowing machine for materials like PET. Tensile testing using UTM machine for stents, hypo-tubes

The design of Catheters, Stents, using Solid Works Software, our integrated process eliminates the need for multiple vendors and can include everything from concept generation, engineering, and prototyping to manufacturing and packaging.

The process developed for extrusion of Catheters, hypo-tubes, FMEA analysis, and transfer to manufacturing.

EDUCATION:

Masters in Plastics Engineering

University of Massachusetts, Lowell, MA

Bachelor of Polymer Science and Engineering

Mysore University, Mysore, India

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