Software Engineer

Ahmed N. Hasib

**** ******** ****** **., *******, MN 55432

763-***-****(C)

E-Mail: *******@*****.***

ISO 13485- 21 CFR part 820 QSR

** *** **** **

Validation (Software, Process,)

Audits

Software Testing

CAPA

ANSI/AAMI/IEC 62304

Design Control

SUMMARY: Dedicated Software Quality and Validation professional with special skills in Medical Device software quality, software verification and validation techniques. Skills also include software development process per IEC62304, Quality and Regulatory requirements for Medical Device industry A strong team player and leader with the ability to communicate up and down the ladder, solve problems and oversee entire software development and Validation process. Committed to meeting regulatory requirement as well as business objectives.

IS

EDUCATION: Master of Science in Software Engineering, University of St. Thomas, St. Paul, MN

Bachelor of Science, (CIS) Minnesota State University, Mankato, MN

COMPUTER Languages: SQL, Oracle SQL+, Visual Basic, C/C++, HTML

SKILLS: Operating Systems: MS-DOS, Windows 3.1, 95 & 98, NT, Win2K, XP, & Linux, UNIX Hardware: IBM, IBM-AS 400, and Macintosh

Software: Documentum, Agile, MS-Office/Outlook PVCS Tracker, Visual Test, Toad, Rational Clear Quest/ Case, FMEA6, HPQC, Cognition Cockpit, Track Wise, Enovia, QA Doc

Enterprise Systems: Trackwise, Oracle, SAP

Training: AANSI/AAMI/IEC 62304, Design for Lean Sigma, Structured software testing, Medtronic System Validation Methodology (MSVM), CRHF Lean Design Control methodology

Certification: ASQ CSQE Certified Software Quality Engineer; CQA Certified Quality Auditor

Certified Lead Auditor: ISO13485 (Medical Device)

JOB EXPERIENCES:

09/20013- Present MEDTRONIC CRDM

Principal Product Engineer (Software & Services)

Partner with Technical Sourcing and Commodity Management to provide both development and continuity support for Software Products and Service Suppliers

Established Software Validation Procedure to be implemented in the sourcing department

Subject Matter Expert in software and service quality Risk analysis for software and service suppliers

Responsible for processing product change notification and a primary key of contact for software and service suppliers for Product Change Notification

Responsible for assessing software suppliers to be compliant with MDT corporate supply change control

Conduct supplier audits as an ISO13485 lead auditor for auditing MDT CRHF software and service suppliers

Responsible for timely, accurate, effective, and efficient coordination, scheduling, planning, execution, and reporting of supplier audits.

Formed audit teams for supplier audits based on the expertise and background of the process and project knowledge

Perform timely reviews of CAPAs (related to audit observations) for accuracy and acceptance, providing recommendations for CAPA improvements to resolve non-compliance issues, as well as monitor and track CAPA implementations to closure.

Responsible for creating audit plans and agendas in alignment with the requirements of ISO 13485, IEC 62304, ISO 14971 and QSR820 and/or any other applicable standards

Responsible for creating audit reports capturing every details of audits including findings, rating the findings and communicate back to the suppliers

Responsible for getting audit responses from the suppliers

Responsible for recording and tracking audits in TrackWise audit flow.

10/2001- 06/2013 MEDTRONIC CARDIOVASCULAR, Brooklyn Park, MN

Principal Software Verification and Validation (Quality/Mfg[GxP]/Equipment System Software)

Served as internal validation subject matter expert and provide expert guidance in interpreting governmental regulations, agency guidelines and Medtronic internal policies in specific to validation to assure compliance.

Served as an internal software validation expert and work with cross-functional groups/sites for software validation support.

Established, Implemented and Maintained Software Validation procedures by incorporating quality, regulatory and Medtronic Internal policies in specific to validation to assure compliance

Managed Validation Activities with Development, Manufacturing, Operations and Quality and other groups per business need.

Provided overall direction and software validation support through out the Cardiovascular organization to ensure software systems are compliant to CV and FDA, QSR, ISO and other relevant Industry standards.

Oversee the completion of projects through the development and approval of validation schedules, validation master plans, validation protocols and reports for systems to support Cardiovascular validation plan.

Worked cross-functionally interacting with engineers and leadership in the Manufacturing, R&D, QA and IT/IS department to implement, update or control any Software changes and revalidation.

Support, mentor, train and educate validation owners in planning and executing the validation processes, best practices, and record/documentation content.

Led and provided validation support, developing test protocols and performing test execution for Cardiovascular system G(x)P and non-product software’s .

Developed test protocols (IQ/OQ/PQ) in accordance with requirements document for new or redesigned in-house developed and commercially of the shelf software (Stand-alone, Client Server and Web) to assure that the software used will perform as intended, and meet company and regulatory requirements.

Reviews and approves protocols, reports and datasheets generated by during testing

Provided support to internal and external audits and inspections related to validation.

Supported Test Method validation working with Reliability engineer.

Supported Manufacturing IQ/OQ/PQ working with Quality and Manufacturing group.

21 CFR Part 11 (Electronic Record and Signature Regulation) Coordinator

Coordinated all 21 CFR Part 11 activities in all Cardiovascular sites and act as a main liaison with the corporate headquarter

Provided 21 CFR Part 11 Training to all CV sites

Created and updated 21 CFR Part 11 Business Unit Renovation plan for Cardiovascular business

Ensure validation of systems that are in-scope of 21 CFR Part 11

Conducted system validation assessment and work as an SME for 21 CFR Part 11 regulations.

Communicated the 21 CFR Part 11 Business Unit Renovation plan with Management and different sites to gather status update project tracking

Principal Software Quality Engineer (Subject Matter Expert)

Served as a key team member in harmonizing and maintaining, coordination of software development and validation programs. Played key role in contributing as a member of the product development team representing design assurance function.

Established, implemented and maintained software development policy and standard operating procedures in compliance with FDA, ANSI/AAMI/IEC and other regulatory agencies.

Consistently monitored and tracked progress of software development and V&V work, ensuring compliance to software development and validation plan

Reviewed and approved assigned controlled documents (e.g. Std. Operating process, work instructions, Design docs, engineering specs and validation documents), ensuring work products meet Internal and regulatory requirements

Participated in software product safety risk management activities such as DFMECA which conformed to ISO14971:2009 for PEMS (software)

Conducted design reviews (e.g. High and Low level, Requirements, Verification and Validation) and test readiness review for PEMS device software ensuring on going review and audit consistency.

Provided technical guidance for preparing software documentation for regulatory submission-510K and special 510K for commercial releases of Medical devices.

Led communication initiative with software vendors/contractors, ensuring the schedule and all the deliverables and final product met all of the requirements of development methodology.

Designed and delivered training on software development and validation SOP’s, on 21 CFR Part 11 regulation

Led successful completion of software CAPA’s using Track Wise CAPA process

Additional Responsibility- Product Quality (non-Software): (03/06-12/2007)

Apply quality expertise to ensure effective compliance to internal and external quality system requirements.

Support systems for the identification, analysis, correction and prevention of quality issues

Reviewed and approved qualification and validation test protocols and reports for design changes.

Reviewed and approved changes to currently manufactured products for enhancements and corrective actions to address process, design, and material problems.

Drove Disposition of non-conforming product/component.

Evaluate and make recommendations concerning product field performance and returned product analysis

03/98 07/01 Software Test Engineer, Datacard Group, Minnetonka, MN

Lead Test Engineer (Manual Testing Projects):

Reviewed Software Requirement Specifications (SRS) and Product Development Documents (PDD) to prepare test cases

Provided time, resource, and equipment estimates for projects to the core team

Prepared test plan and test cases in accordance with the SRS for Planned testing schedule and resource allocation

Distributed test cases to the other test team members according to test priorities

Executed test cases

Prepared test reports at the end of each project using metrics data gathered during testing phases

Prepared day to day testing progression chart using Excel spreadsheet and PVCS Tracker Reporting

Communicated with core team, developers and test team on bug findings, tracking and fixes

PROJECTS:

Led Medtronic Cardiovascular’s software development methodology streamlining effort to adopt Medtronic corporate software development policy and AANSI/AAMI/IEC62304 requirements.

Participated in developing Medtronic’s corporate software policy

Key member of Medtronic’s 21 CFR Part 11 working group

Led and provided expertise on different categories of software validation projects as per FDA’s Software Validation Guideline and Medtronic’s System Compliance Methodology.

Contact this candidate