Julius Okopi

760-***-****

adzuw9@r.postjobfree.com

Experience summary

Over 30 years’ industry experience:16 years in Semiconductor and Telecommunications industry as a Systems Engineer and 15 years in Medical Device and IVD industry as a Software/Systems Design Quality Engineer. Primarily responsible for supporting medical devices product development to assure compliance with FDA and EU regulations as summarized below.

oSoftware Development Life Cycle (IEC 62304)

oCreating of good software/system software requirement specifications (IEEE 830:1998) and associated Traceability Matrix

oSDLC Models (Agile. Waterfall, Iterative)

oSoftware Design for Reliability (DFMEA, FTA)

oHuman Factors (Usability) Engineering (IEC 62366)

oSupport Development & Validation of Embedded Software

oSupported Non-Product Software Validation IQ/OQ/PQ - based on GAMP5 / ISO TIR 80002-2)

oSupport Development & Validation of Window-based software

oSupport Development & validation of Cloud-based software

oSupport Risk Management (ISO 14971, ISO/TIR 80002-1)

oSupport Complain Handling - CAPAs

oSME Computer System Validation – CSV (GAMP 5, ISO/TIR 80002-2)

oSupported Auditing activities as necessary (MDSAP, FDA, DEKRA))

oSaMD

oAIMDD

oMDSAP Audit

oMDDS

oMDR / IVDR

oGDPR

oNPD projects

oDesign Change project

oDHF Remediation Projects

oDesign Control (21 CFR 820.30)

oData Integrity (21 CFR Part 11)

oFDA requirement for Cybersecurity (pre-market and post-market submission)

oNIST Cybersecurity Framework

oUse of OTS in medical device software

Experience Depth

My contributions in medical device industry includes, but not limited to the following:

Managed software development for new products introduction (NPI)

Led Software Design Quality for New product (NPD) development and Sustaining projects from concept phase through commercial releases.

Led the development of Automated test framework for verification of PC and Web-based software (used for supporting Ventilators and Remote patient monitoring systems)

Provided oversight on development of several embedded software systems and ensured compliances with IEC 62304 and Electrical Safety Standard – 60601 series.

Provided IEC 62304 training to the entire software development, Software V&V and quality engineering teams in my organization.

Conducted gap analysis in SDLC processes and updated the associated document to assure compliance for transitioning from the 2006 version (IEC 62304:2006) to 2015

Supported RA in FDA 510(k) submission for Medical Devices containing software by preparing the software submission package.

Provided training to various development teams on various SDLC models (Agile, Waterfall, Evolutionary, etc.) and strategies for choosing the right model for each software development project.

Contributed to Cybersecurity planning for both post and premarket submission.

Authored Cybersecurity Risk Assessment document for a Class II medical device.

Developed SOPs form Non-Product Validation processes based on ISO/TIR 80002-2 and GAMP 5 standards.

Supported the development of several Class II and Class III medical devices from concept phase through market release, while assuring compliance with Design Control - 21 CFR 820.30 and ISO 13485

Led initiative for remediation of Design History File (DHF) to bring product development process into compliance with the organization’s QMS.

Led initiative to validate several non-product software systems (Computer Systems Validation) with a CSV process that is based on GAMP 5 and ISO/TIR 80002-2

Collaborated with Complaints department on Post-Market Surveillance activities, Field Actions, and performed Trend Analysis and periodically provided the associated Status Report to senior management.

Provided oversight to ensure all CAPAs are addressed in a timely manner.

Mentored and trained engineers at all levels to improve the overall competence of the organization. Training topics include, but not limited to the following:

oMedical Device Software Development Process IEC 62304

oGuidance for selecting appropriate Software Development Life Cycle Model (SDLC) for a project.

oRisk Management Process based ISO 14971:2019

oSoftware Risk Management based on TIR/ISO 80002-1

oRisk – based approach to non-product software validation based on GAMP 5, ISO TIR 80002-2

oUsing Agile SDLC model for medical device software development

oRisk analysis tools, Hazard Analysis, dFMEA, pFMEA and FTA

oRecommended best practices for writing good functional requirements based on IEEE 830:1998

oDesign Control Process: 21 CFR 820.30 and ISO 13485

oData Integrity: 21 CFR Part 11

oSoftware Validation (General Principle of Software Validation – FDA Guidance to Staff and Industry)

oVerification and Validation of Product Software

oSoftware as a Medical Device (SaMD)

oFDA guidance for 510(K) / EU submissions of medical device containing software.

oCreating and maintaining Traceability Matrix)

oGuidance for software containing COTS/SOUP

oPre- and Post-Market Cybersecurity Requirements

Tools Knowledge: Visual Studio, SVN, JIRA, Github, Circle CI, JAMA, AGILE, MasterControl, Polarion, TFS, DOORS, C/ C++, OO, Windows, Visio, National Instrument GPIB (IEEE488 Standard)

Product knowledge: Ventilators, Infusion Pumps, Remote Patient-Monitoring System, Imaging System for detecting breast cancer, CGM.

Personal attributes: Excellent oral and written communication skills, presentation skills, Leadership, and mentorship, experience working with many cross-functional teams.

Education

Electrical Engineering (associate degree)

Isle of Wight College of Technology, Newport, England

Computer, and Systems Engineering (bachelor’s degree)

Loughborough University of Technology, England

Electrical & Computer Engineering (Doctorate level Degree)

Chalmers University of Technology, Sweden

Guest Research Scientist (Post Doctorate)

University of California, San Diego, Computer Vision Laboratory, School of Electrical, Engineering

Summary of Product knowledge

Experience with several medical devices (Mainly Class II and III medical devices)

oInvasive and non-invasive mechanical ventilators

oInfusion Pumps

oCombination device Infusion Pump (DUODOPA® (Levodopa/Carbidopa Intestinal Gel) for treating Parkinson decease patients.

oMobile App for blood Glucose Monitoring

oEmbedded Software for Continuous Blood Glucose Monitoring

oRemote Patient Monitoring system

oActive Implantable Medical Devices AIMDD - (Nerve Stimulator Device for Pain Management)

oCatheter and Manometry system for Acid Reflux diagnosis

o3D Imaging System (Tomosynthesis) for breast cancer detection

oSeveral IVD products, Including Urine Analysis products.

Professional History

Vivera Pharmaceutical 8/ 2023– Present

Member of Advisory Board – Software Engineering/ Design Quality SME

VALTEC Medical, Inc, San Diego 9/ 2021 – Present

Principal Software QA / Project Management Consultant

Providing software quality engineering consulting services to multiple medical devices in areas of medical device software development to assure compliance with all applicable FDA and European regulations.

Recent clients and projects include the following:

Vivera Pharmaceutical: Member of Advisory Board on Software design Quality

Dexcom, Inc. Validation of PLM, including assurance of Data Integrity (CFR Part 11)

LifeScan, Inc. Provided Design Software Design Quality support for Continuous Blood Glucose Monitoring (CGM) software (both device and mobile App Software – SaMD)

Dexcom. Oversight on Validation of Enterprise Software (PLM)

Medtronic, Inc, Santa Clara: Lead the software development for their New Generation Manometry System Software to assure compliance with IEC 62304, ISO14971, Design Control, and trained the development team on all applicable standards and regulations. Managed development of new Generation Manometry system

Johnson & Johnson Inc. (Robotic Division, Santa Clara): Supported Verification & Validation activities (Reviewed Verification Plan, Verification Protocols, Traceability Matrix, Verification Reports, etc.) for their new Endourology software system to assure compliance with internal verification process.

Nevro, Inc, Redwood City: Supported Verification & Validation activities (Reviewed Verification Plan, Verification Protocols, Traceability Matrix, Verification Reports, etc.) to assure compliance with internal verification process.

Omnicell, Inc, Pittsburg, PA: Provided training to R&D and software development teams on regulations and standards that apply to medical device software development, including IEC 62304, ISO 14971, ISO/TIR 80002-1, ISO/TIR 80002-2, 21 CFR 820:30, etc.,

INOVIO Pharmaceutical, Inc. – San Diego, CA 4/2021 – 9/2021

Manager Software V&V Engineering

Managed the V&V Team and lead the validation effort for a class II medical device software.

Documented the Cybersecurity Plan for both pre- and post-market submission.

Authored the Cybersecurity Risk Assessment document for a Class II medical device that is under development.

Worked with TUV and CENSUS (in Europe) on Cybersecurity testing of the medical device and authored the test report.

Mentored team members on best practices for software V&V process

Authored the non-product software process based on TIR/ISO 80002-2

Provided guidance on review of SDLC process to assure a compliance with IEC 62304

Vyaire Medical, Inc. – Irvine, CA 9/ 2019 – 4/2021

Senior Principal Engineer – Design Assurance

Leading design software quality assurance effort for various classes of ventilators (Invasive and non-invasive ventilators)

Authored emergency use authorization (EUA) application to allow the use of one ventilator model to support a wider patient population during the COVID-19 epidemic.

Mentoring and training engineering staff: providing training on several topics listed above.

Illumina, Inc. – San Diego, CA 9/2018 – 9/2019

Senior Staff Software Quality Engineer / SW Validation Lead

Trained software development and quality teams on application of IEC 62304:2015

Authored computer systems validation process (based on GAMP 5) and trained teams on its application.

Developed a technique to reduce the probability of software failure and hence reduce overall risk associated with software failure.

Provided training on recommended practice for writing good functional requirements based on IEEE 830:1998,

Provided guidance on adopting risk-based approach to validation, writing effective, and efficient verification protocols.

Arthrex – Santa Barbara, CA 4/ 2018 – 9/ 2018

Senior Software Quality Engineer / SW Validation Lead

Created a procedure for Software dFMEA.

Risk-based approach to Computer Systems Validation (CSV) based on GAMP 5Updated an existing SDLC procedure to comply with IEC 62304:15)

Alere/Abbott – San Diego, CA 4/2017 – 9/ 2018

Principal Software Quality Engineer / Software Validation SME

Led the initiative to validate several enterprise software systems (EDMS, Master Control, JIRA, etc.)

Mentored and trained engineers on best practices for medical software development (IEC 62304), requirements analysis, and computer systems validation.

Revised existing CSV process to improve the efficiency of validation of non-product software.

Beckman Coulter, Inc. – Chatsworth, CA 10/ 2015 – 3/ 2017

Staff Engineer, SW Design Quality in R&D / SW Validation Lead

Led Design History File (DHF) remediation effort aimed at bringing the organizations QMS into compliance with QSR.

Led a major design change project that saved the company over $18 million dollars.

Provide mentoring (both upstream and downstream) across the entire organization by training engineering staff on critical software quality related subject matters such as IEC 62304, ISO 14971, Data Integrity

Acted as Software Quality Subject Matter Expert (SME) during external audits (FDA and Danaher)

Valtec Medical 5/ 2013 – 10/ 2015

Principal Software QA Consultant

As an owner and the principal consultant of my software quality engineering consulting business, provided short term software quality engineering services to the following clients:

AbbVie, Inc. – Chicago, IL 10/ 01/2014 – 10/ 2015

Quality Engineer

Provided technical leadership on software quality engineering and V&V effort for a new product (DUOPA Infusion pump for treatment of Parkinson’s disease patients).

Jointly Health, Inc. – Orange County, CA 12/ 2013 – 5/ 2014

Quality Engineer

Provided technical leadership on software quality engineering and V&V effort for a new product (REMOTE PATIENT MONITORING SYSTEM)

Johnson & Johnson (ASP) – Irvine, CA 5/ 2013– 7/2013

Quality Engineer

Provided Software Quality Engineering and V&V support for a legacy product (Advanced Sterilization Product - STERRAD 100).

CareFusion, Inc. – San Diego, CA 3/2011 – 2/ 2013

Principal Quality Engineer

Provided quality support for several software products, including the enterprise web-based application – the Infusion knowledge portal (IKP)

Reviewed Design History File to ensure completeness of project deliverables before every phase transition.

Provide training to software engineers on how to write good software requirements specifications, V&V plan, protocols, reports, etc.

Philips Healthcare (Respironics), Inc. – Carlsbad, CA 5/2007 – 10/ 2010

Manager, Software V&V Manager

Collaborated with R&D on the development of V60 ventilator by collaborating on the development of design input documents, risk management activities, code reviews, etc.

Led the V&V team to successfully complete the V&V activities the V60 Ventilator

Worked with Regulatory Affairs (RA) department to support 510(K) submission and with marketing department to market launch the various products.

Cardio Dynamics, Inc. – San Diego, CA 10/2006 – 5/ 2007

Software Design Quality Manager

Staffed the Software V&V team and successfully led them to complete a several major Design Change Projects for their Impedance Cardiograph (ICG) products (BIOZ DX)

Supported RA in 510K submission and worked with the marketing department to launch the product.

Conexant Systems, Inc. – San Diego, CA 8/1999 – 5/2006

Senior Software/Systems Engineer

Led a Systems Verification team to develop an enterprise-wide Test Automation System for verification of embedded software in several chipsets, e.g., DSL, SONET, CODEC, etc. resulting in reduction of verification test cycle from three weeks to one week and produced a 5 million dollar saving for the company.

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