Niranjan Ray, Ph.D

Los Ángeles, California ac4wms@r.postjobfree.com 818-***-**** (Cell)

Summary

An accomplished Design Assurance Engineer with over 19 years’ experience serving as lead core team member of product development team. Participated in all phases of product development life cycle for Implantable Medical Devices, Assay Development, and Clinical Diagnostics of microorganism with antimicrobial susceptibility, ensuring highest quality in processes, products, and services. Authored Product Qualification Test Plan/Report (QTP/QTR), performed testing to validate device design, ensuring the devices met the product specifications & user needs. Certified Six Sigma Green Belt, using Statistical Process Control tools. Trained team members and mentored engineers. Developed and maintained product Quality Assurance meeting customer needs, Quality standards and Regulatory requirements. Experienced and Ensured compliance of:

ISO 14971 & ISO13485 (QMS)

Design Controls & 21CFR820

DFMEA, and PFMEA

Test Method Validation

IEC 62304 and IEC 60601-1

Risk Management, FTA, FMEA & SPC

Complaint Handling & CAPA

IQ, OQ and PQ

DHF audit and Remediation

Root Cause Analysis

Supplier Audit & Supervision

Six Sigma Green Belt

Technical Skills

Languages:

C/C++, Visual Basic, FORTRAN and PASCAL

Operating Systems:

MS DOS, Unix and Shell Programming, MS Window XP, LAN/WAN

Tools:

MS Word, Excel, Power Point, System Analysis and Design

Database:

Oracle DBMS, SAS, dBase Programming, FoxBASE, SQL, Relational

DBMS, Client-Server, PowerBuilder, FoxPro, DOORS

Product Validation Testing:

Product Qualification Test Plan/Report (QTP/QTR), Sample sizing, Product Specification based testing, Validation of Test Methods, Conformance to Specifications, and documenting the results in QTR

Hardware Testing:

Test Stations Validation (HP9492) for Wafer testing. GenRad Test Systems for Hybrid testing. Digital Telemetry Module (Board) in-housed in Merlin PCS 3650 Programmer for Pacers testing

Firmware:

Ischemia (blockage of an artery) monitoring stored in ROM device. Unit testing and Bench testing

QA Testing:

Test Plan/Report, Requirements based testing, Black box and White box testing, Manual & Automatic testing, Bug tracking, Validation of Software and its life cycle support, Software Configuration Management

Source Control:

PVCS, ClearCase

Defect Tracking:

DDTS, ClearQuest

Hardware:

Merlin PCS 3650, HP82000, HP9492, GenRad & AG Hybrid Test Stations

Professional Experience

DJO Global,San Diego, CA, Consultant (Consultant Tata Consultancy Services Inc.)–July,2017–Sept,2017

Updated Software Requirement Spec. for Agile-Oracle Database, using Adapter.

Created draft System Validation Plan to test the requirements, using test cases and test acceptance criteria. Also created Traceability Matrix. Reviewed to update IQ, OQ and PQ documents.

ASP (Johnson & Johnson Co, Irvine, CA, Consultant/ Consultant of TCS Inc. – May, 2016 – July, 2017

Created pFMEA for STERRAD NX and 100NX System based on Installation and Qualification Customer Guide.

Collaborated with cross-functional team members to evaluate impacted deliverables and risks (dFMEA and SRA) associated with design change Plan and risk mitigations.

Worked as a Quality core team member of Product development team for Design Control.

Trained, and mentored Sr. Engineers on compliance of Regulatory requirements & Quality Standards (SOP).

Reviewed V & V Protocols, and Software Integration Test Plan & Reports. Compared with Software Requirements Specification for traceability of test cases & test acceptance criteria.

Managed and prioritized multiple Projects and tasks with cross-functional team members to meet deadline.

Created Report on Management of Cyber Security in Medical devices for FDA Premarket Submission.

Beckman Coulter, Sacramento, CA (Employer: APN Software Inc.) Feb, 2015-April, 2016

Consultant (Quality Systems & Compliance)

Worked as a core team member of the projects for Design Control, and Product Development life cycle. Performed internal audit of DHF & DMR of the Projects to evaluate gap assessments for remediation, ensuring readiness for external audit.

Participated with cross-functional team members in evaluation risks associated with design changes and provide risk assessment mitigations.

Implemented and enhanced software validation processes and documentation system in accordance with the FDA guidelines and IEC62304.

Reviewed software requirements, Design Summary, Verification Plan to test the performance and functionality of the software for Panel delivery Software. Also reviewed code, configuration management, Verified test cases, Test Acceptance Criteria. Audited Defect Tracking system, and Requirement Traceability Matrix.

SIEMENS HealthCare Diagnostics, Sacramento, CA July, 2013 - January, 2015

Consultant (Quality Engineer E5)

As a core team member of the projects for Design Control, and Product Development life cycle, audited Project documents (DHF, DMR & other documents), comparing SOPs, and addressed noncompliance issues per SOPs and regulatory requirements as a part of continuous process improvement.

Participated with cross-functional team members in evaluation of risks associated with design changes and provide risk assessment mitigations.

Reviewed software requirements for use of Clinical diagnostic lab. Also reviewed Verification & Validation Plan to test the functionality of the software for Panel delivery. Performed code walk-through, reviewed configuration management, Verified test cases, Test Acceptance Criteria. Audited Defect Tracking system, and Requirement Traceability Matrix.

Investigated CAPA for its resolutions.

ST. JUDE MEDICAL INC. - Cardiac Rhythm Mgmt. Div., Sylmar, CA Aug. 1996 – Dec. 2012

Sr. Design Assurance Engineer, Lead Core Team Member of Product Development Team

Authored Quality Plan/Report, Risk Management Report, IEC 62304 (Compliance Summary Report) & IEC 60601 Report (for TUV and FDA). Created CAPA and Implemented the requirements of CAPA.

Followed 21CFR 820 (QSR), GMP, ISO 9001, ISO13485, and ISO 14971 for product life cycle.

Created Product Qualification Test Plan/Report (QTP/QTR). Selected sample size, performed testing to validate device design, ensuring the devices met the product specifications as well as user needs and intended uses. Design validation includes software validation, Test Methods validation & risk analysis. The test results were documented in QTR.

Reviewed all deliverable documents (Product Specifications, Firmware, System and Software, Regulatory and Marketing) prior to FDA submission for product qualification.

Performed internal audit of defect tracking system (Clear Quest) to identify any defect not in terminal state (Verified, Postponed, closed as no issue), reducing 15% defect submissions and investigations and saving time of Change Control Board.

Coordinated with cross-functional team members to establish system and application software risk assessments, ensuring on-time completion of Risk Management Report.

Audited Design History File (DHF) and DMR, ensuring readiness for external audit.

Managed and prioritized multiple Projects and tasks independently in cross-functional team environment to meet the deadline.

Hardware and Software Validation:

Wrote Validation Protocol and Report to validate software for Wafer testing, software for Hybrid testing and software for Digital Telemetry Module (Board) testing.

Performed repeatability testing to validate Test Stations (Hardware: HP9492 and GenRad), resulting in yield improvement.

Installed software on Merlin PCS 3650 Programmer to test medical devices (Pacers and ICD) before shipping to market. Documented test results.

Designed and developed strategies for software Validation Protocol and Report. Tested to verify software performance and functionality, meeting the requirements. Created test cases, bug tracking system, and regression testing.

Audited vendors’ development process. Presented lectures to train offshore (vendor) engineers, ensuring full compliance with established standard and procedures for software development process, testing, configuration management, and documentation.

Trained, mentored, and supervised new hired engineers to comply with quality and regulatory standards.

Participated in IQ/OQ and PQ activities, qualifying equipment using test sample size selection and test method validations.

Applied statistical tools to analyze data (data types, accuracy vs. precision, mean/range /standard deviation), making recommendations to monitor and improve the process.

Awarded Six Sigma Green Belt certification by minimizing False Failures, and reducing test time of software using statistical process control (SPC) tools, saving about $316K per year.

Hewlett Packard, HP EEsof Division, Westlake Village, CA 1995 - 1996

Sr. Software Quality Assurance Engineer

Compared and verified PC based software products with that of UNIX based Software and checked user manuals, recommending manual update.

Ensured full compliance with the software development process for RF/Microwave Design, to test, verify and validate the software requirements & documentation.

Tracked nonconformance reports and bug action records, fixing and verifying the software.

Wrote test scripts, verifying functionality of Software using “Application Extension Language”.

EDUCATION

Ph.D. (Engineering), MSEE and BSEE (Honors): Jadavpur University, India

C++/Unix OS and Visual Basic 4.0 - UCLA/California State University, Northridge, CA

PROFESSIONAL CERTIFICATIONS

Achieved Six Sigma Green Belt certification at St. Jude Medical Inc., Sylmar, CA

Leadership and Project Management Training, University of California, Los Angeles

Obtained Certification as Competent Toastmaster from Toast Masters International for public speaking and leadership development.

AWARD

Received Performance Awards four times from President of St. Jude Medical for supporting cross-functional team members and meeting projects deadline.

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