Engineering Product Development

SATHVISHA LANKA

Email Id:**************@*****.***

Phone No: 510-***-****

PROFESSIONAL SUMMARY:

Developing risk management strategies, plans, compliance and documentation; Use, Design and Process FMEA.

Develop and document test plan protocols, test procedures and test reports for the MultiCross catheter.

Acted as key contributor to address FDA response regarding 510(k) application with special assignment projects related to coating integrity, tensile testing, colorants, packaging, aging, particulate evaluation, SEM Analysis of NiTi Scaffold, etc.

Perform IQC, Final QC and lot release testing activities.

Work with R&D to devise design verification plans and test methods for products based on performance specifications and standards.

Ability to perform GAP analysis and preparing Remediation plans with knowledge of project Management.

Proficient in Lean Manufacturing concepts.

Experience with reviewing Device Master Records (DMR).

Clear understanding and working experience in CAPA Systems. Extensive experience in Process improvement, Verification and Validation, Risk Management and Quality Engineering in the medical device industry.

Hands on experience in Process Development, Process parameter control and Continuous Quality improvement.

Strong working knowledge on the FDA regulations, 21 CFR Part 820, Part 11, ISO 14971, 13485 and 11607.

Worked on Risk Management (RM) Strategy and Plan.

Hands on experience in Design controls and DHFs.

Worked in PLM environment (Enovia/Agile PLM, Windchill PDM, Omnify)

Expertise in risk based sampling and Minitab.

Hands on experience using CAD, Solid Works and CATIA V5 design tools.

Knowledge and experience working in GMP (Good Manufacturing Practices) and GDP (Good Document Practices).

Created and Updated SOPs and trained users on SOPs for various systems.

Hands on experience in Design controls and DHFs. Evaluated the process Repeatability and Stability.

Conducted Gage R&R Studies.

Review modified product designs for quality characteristics, including manufacturability, testability, biocompatibility, sterility and conformance to product requirements.

Professional Experience:

Varian medical systems,Milpitas,CA

Quality Engineer- Dec 2016 to June 2017

Performed monitoring, sampling and testing to validate equipment, systems and processes per validation protocols.

Provided Engineering support to product and process design, including risk management review, classification of quality characteristics, design inputs and review, technical drawings and specifications, and design verification and validation.

Reviewed and analyze in-process and finished product testing and inspection results to ensure the Validations met company top level procedures and FDA regulations.

Responsible for initiating, implementing and completing change control, deviations, investigations, impact/risk assessments, root cause analysis and CAPAs

Worked with R&D, and QA to improve manufacturing processes, designs, inspection methods for MPI and documentation.

Reviewed product and process control methods documents to ensure that criteria for identifying critical control points are met.

Developed CAD drawings for newly acquired facilities, updating and maintaining existing facility documentation.

Wrote, Reviewed and approved Engineering Change Orders and Engineering Change Records, Graphics, Product Development History documents, IQ, OQ, PQ for accuracy and correctness.

Performed Installation (IQ), Operational. (OQ), and Performance Qualifications (PQ) on new tooling, equipment and software.

Wrote, Reviewed and approved all design control risk management documents such as plans, hazard analyses, and design and process FMEA's, and reports.

Coordinated validation activities with other functional groups.

Executed protocols and test procedures pertaining to validation activities.

Developed test methods/procedures to support product validation.

Responsible for Creation, evaluation, and validation of product and process test methods.

Primary Healthcare, India

Process Engineer (June 2014 to April 2015)

Worked with cross functional groups conducting analysis of NCMR's/ NCR's, with the purpose of evaluating the underlying issues and finding long-term solutions.

Experienced with Quality tools/methodologies including: SPC, DOE, GR&R, FMEA, CAPA, complaint investigation, process validation (IQ, OQ, PQ) and FDA standards.

Performed statistical analysis using Minitab to determine sampling plan and acceptance criteria for effectiveness verification of CAPA.

Maintained Change Control documents for existing systems and generated appropriate validation documentation.

Defined execution of Equipment Qualification, Test Method Validation (TMV) and Process Validation Protocols (IQ, OQ, PQ) and reports.

Responsible for creating validation master plans and developing validation specifications for various equipment.

Developed and executed validation protocols for qualification (IQ / OQ / PQ) of medical device manufacturing equipment and utilities.

Experience with equipment and line process validations (IQ / OQ / PQ).

Responsible for providing engineering support in manufacturing processes as well as perform root cause analysis of existing products.

Facilitated the CAPA process for process controls, Calibration, material control: CAPA initiation, correction and Root Cause Analysis / Investigation plans.

Complete Gage R&R studies on test methods used for design verification, receiving inspection, in process checks, and returned products analysis.

Provided training for production team members on Standard Operation Procedures (SOP) and Work Instructions on any new or modified quality documents.

Responsible for investigation and documentation of all validation related failures including determination of assignable root cause. Determined impact of failures on validation study.

Partnered with Product Development, Manufacturing Engineering and Operations to complete FMEA analysis, systems evaluation and process validation.

Education:

Master of Science in Electrical Engineering, North Western Polytechnic University, Fremont, CA

Bachelor’s Degree, Electronics and Communications Engineering, Vignan’s Lara Institute of Technology and Science, Vadlamudi,Andhra Pradesh, India

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