Biomedical Engineer

SOWMYA SURAPANENI

***** ******** **, #*** *****: 818-***-****

Sherman Oaks, CA-91603 Email : ******@*****.***

SUMMARY

Quality Design Assurance Engineer with 4 years of experience in a FDA regulated medical device environment. Demonstrated success in introducing new product transfers from R&D to production. Implemented and managed new processes to improve yield, reduce cost, cycle time and enhance performance and reliability. Troubleshot existing processes to improve quality and productivity.

CORE COMPETENCIES

Engineering Documentation (IQ,OQ,PQ) Regulatory Compliance

New Product Introduction (NPI) Experimental Design Activities

Engineering Change Order (ECO) Process Development/Implementation

Quality Assurance/Standards GMP guidelines & Procedures

WORK EXPERIENCE

Medtronic Minimed, Northridge, CA June 2007 - present

Design Assurance Engineer – Implantable Sensor

• Successfully completed R&D product transfer of low suspend glucose sensor that was sent for clinical trials and approved for OUS shipment.

• Experienced in writing and executing many process validation plans and reports. (e.g. IQ – OQ – PQ – ETP/R – PVP/R – QTP/R).

• Performed relevant testing required for analyzing sensors and peripheral products, based on internal testing requirements, and current compliance and regulatory standards.

• Applied Design of Experiments (DOE) methodologies and statistical process controls (SPC) to develop and improve manufacturing processes.

• Generated approximately $300,000 per year savings by characterizing electrode plating process to shorten cycle time and increase throughput.

• Implemented CAPA practices, Risk Analysis and FMEA to eliminate errors and to fix processes.

• Participated in standard product design techniques based on Manufacturing, Assembly and Serviceability (DFMA/DFS).

• Used semiconductor processing techniques to produce electrochemical sensor arrays and scaled-up processes specific to the manufacture of an electrochemical glucose sensor.

• Identified new processes capable of reducing the assembly costs of commercially available sensor products.

• Worked with cross-functional teams across the organization and geographies to transfer developmental projects into a regulated manufacturing environment.

• Prepared detailed part and process specifications from high-level product specifications.

• Supported senior scientific staff in the area of literature search for viable technology associated with product development of diabetes management.

• Produced supporting documentation which meets FDA, GMP, and GLP standards.

• Produced engineering reports containing statistical analysis when necessary in support of process characterization and validation activities.

• Created Engineering Change Requests (ECR) and Engineering Change Orders (ECO).

• Troubleshot and maintained an electrochemical fluidic system.

Student Assistant Research under Dr. John M.Cavanaugh, Biomedical Engineering, Wayne State University, Detroit, MI Aug 2005- May 2007

• Designed platinum cuff electrodes to measure diffuse axonal injury in rats

• Collected data for research on child occupant safety, frontal, rear and side impacts

• Participated in grant development and submission

• Maintained laboratory supply inventories

• Tested laboratory equipment

• Assisted in acquiring vendor information and bids for equipment or software purchases

ELECTRONICS CORPORATION INDIA LTD., Hyderabad, India Summer 2004

• Learnt the operation and design of Analytical equipments

• Received wide exposure in the area of manufacturing UV Spectro-photometer

SKILLS

Documentation: Microsoft Outlook, Powerpoint, Excel, Word, Visio, Project

Simulation: Minitab 14.0, Medstat.

EDUCATION

Master of Science in Biomedical Engineering Aug 2005 – Aug 2007 .

Wayne State University, Detroit, MI.

Awarded Graduate Professional Scholarship (2006-07) for Research and Academic excellence.

Six Sigma Green Belt Certification.

Bachelor of Technology in Electronics and Instrumentation Engineering Aug 2001 – May 2005

Vellore Institute of Technology (Deemed University), India

PROJECTS

• Alternative materials for glucose sensing – Medtronic Minimed, Northridge, CA Summer 2007

Investigated various materials for electrode fabrication. Performed experiments and tested In-Vitro. Analyzed data and created reports of the outcome.

• Interference rejection – Medtronic Minimed, Northridge, CA Summer 2007

To detect and reduce current interference from agents other than glucose. Investigated Electrochemical and chemical means. Documented the experiments and summarized the work in reports.

PAPERS

• Pain generation in lumbar and cervical facet joints

Technical Assistance with publishing of the paper

• Does acute disc rupture actually exist?-a review

Supported professors in the area of literature search, and creation of the poster

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