SUMMARY:

• Outstanding expertise for both Software and Hardware in Quality Assurance, Business/System Analysis, Project Management, and Validation Engineering:
• Extensive experience (15+ years) in highly - regulated environments with medical device manufacturing companies:
• Performing Quality Reviewing and Verification/Validation of Class I, II and III Medical Devices.
• Performing Qualification of equipment and systems used in the Quality-Control/Manufacture of Medical Devices.
• Particular strengths include detailed knowledge, comprehension, and ability to implement and ensure compliance:
• FDA regulations QSR, 21 CFR Part 11, 210, 211, 801, 812 and 820
• EU MDR - European Union Medical Device Regulation - (EU) 2017(2021)/745 and EU Annex 11
• ISO/IEC quality standards ISO 9001, ISO 13485, ISO 14971, ISO 15223-1&2, ISO 11607-1&2, IEC 62304, IEC 62366
• IEC 60601 Parts 1&2 (as well as the collateral and particular standards)
• Excellent Technical and Non-Technical Communication Skills, both Written and Verbal:
• Organizes and simplifies complex and multilayered processes and procedures into concise and easy-to-understand presentations and documentation for all user levels. Provides expert-level process improvement guidance.
• Authors and Quality Reviews Standard Operating Procedures, Material, and all SDLC / Verification / Validation Documentation:
• Plans for Projects, Verification/Validation, Software Engineering, Configuration Management, & Implementation, and Maintenance.
• Requirements and Design Specification documentation, including: Intended Use, System and User/Functional Requirement Specifications, Design Specifications, Software Architecture Documents, Engineering Studies.
• Risk Management File Activities/Assessments, and Root Cause Analysis, and related documentation, including: RMP, HRA, SRA, FMEA/FMECA (for Application, Design, Software, and Process), PFMEA/PFMECA, FTA, RMR.
• Both Design and Process Verification/Validation (Testing) documentation, including: Traceability Analysis/Matrices, Test Plans/Cases/Protocols/Reports for all levels and types including IQ-OQ-PQs, UAT/FAT, Black/White Box, System Level, Data-Flow, Stress, Boundary testing, both manual/automated, and Source Code Reviews.
• Enhancement and Defect (Bug) Tracking Analysis/Investigations/Documentation/Resolutions.
• CAPA Analysis/Investigations/Documentation/Resolutions.
• Test Method Validations (both variable and attribute).
• Gap Assessments/Analysis and Remediation of Legacy Systems; DHF Remediation and Index Maintenance.
• Labeling Validation for domestic/international and CE marked products (particularly IFUs, and for multi-languages).
• Knowledgeable and Experienced with Validation and Qualification of Software and Hardware (including related Embedded and Supportive Software):
• Reviewing, Approving, Writing and Executing the Verification and Validation (Plans, Protocols, Reports) for Medical Devices (Software/Hardware) - examples include: Assay Analyzers and Instruments, IPGs (Internal Pulse Generators - neurostimulators), Confidential t and Clinician Programmers, Cardiac Ablation Systems, Catheters, Stents (both coated and non-coated), Peristaltic and Infusion Pumps, Surgical Navigation and Intra-Operative Imaging Systems, MR eCoil Imaging Systems, Dialysis Machines and Monitoring Systems, Blood/Water Treatment Systems, Chest Drains, X-ray Devices and Imaging Systems,, and SOUP/COTS product software and software tools.
• Reviewing, Approving, Writing and Executing Qualifications (IQs, OQs, PQs) of Medical Manufacturing Equipment and Manufacturing Processes - examples include: Automated Bag Machines, Automated Needle Machines, Packaging Machines and Printers, Silk Screen Color Printers, UV Ovens, Heat Bar Sealers, Hot Stamp Machines, Tensile Testers, Tubing Corrugators, Extruders, Injection Molding Machines, CNC Lathes, Ultrasonic Welders, Vibration Welders, PLCs, Scales & Balances, Calipers.
• Support Functions and Applications - examples include: Establishing and Validating PM and Calibration Processes, Conducting Site Inventory, Maintaining Data in Configuration Management Systems, Cybersecurity Processes and Procedures.
• Passionate in applying, maintaining and evolving the principles of Quality, Service, and Teamwork:
• Works well both with others in collaborative cross-functional team efforts and independently with minimum supervision. Provides motivation, and mentoring to others.
• Self-motivated/enthusiastic/ flexible/versatile/adaptable, exceptionally detail-oriented with excellent problem-solving skills.

TECHNICAL SKILLS:

Languages/DBMS: C and C++, Java, Visual Basic, COBOL, SQL/SQL*Plus, Python, Progress, LabVIEW, TestStand, HTML, HML/UML, XML, PLC Ladder logic

Operating Systems: Windows, DOS, UNIX, LINUX, VAX/VMS

Software: MS Office (Word, Excel, PowerPoint, Access, Outlook, Publisher, Visio), MS Project, MS SQL Server, MS Visual SourceSafe, MS Visual Studio, OneNote, Rational, WinRunner, PowerBuilder, Crystal Reports, Report Builder 2.0, XPath Tools, PC-Tracker, DOORS, RequisitePro, Matrix One, PTC Windchill, CATSWeb, Agile, SharePoint, Omnify, Minitab, Cognition Cockpit, TrackWise, TestTrack Pro, Helix ALM, Jira, HP Quality Center, Micro Focus Quality Center, Amazon Web Services (AWS), MS Teams, Zoom.

Hardware: PC computers/laptops/notebooks; mainframe and mini-computers system and peripheral installation, maintenance, memory upgrades, cabling, PLCs, troubleshooting, diagnosis, repair.

PROFESSIONAL EXPERIENCE:

Software Quality Engineer

Confidential, Louisville, Colorado

Responsibilities:

• Reviewed and approved quality system related documentation deliverables for both medical device product and non-product software and hardware.
• Managed and authored quality system documentation for quality system supportive software, developed and executed software test plans and resulting reports.

Software Quality Engineer

Confidential, Boulder, Colorado

Responsibilities:

• Responsible for the overseeing development of embedded software used by the portable LightDeck Analyzer, which is built on advanced planar waveguide technology using disposable test cartridges.
• Managed and authored quality system documentation for software, developed and executed software test plans, managed external subcontractors, maintained server-based code development tools, and was responsible for software version releases, user manuals, and configuration control.

Software Quality Engineer

Confidential, Littleton, Massachusetts

Responsibilities:

• Pre-reviewed, reviewed and approved quality-controlled SDLC documentation for both product and non-product software (both for in-house developed and SOUP), and software tools validations, requirements and risk management files for the O-arm O2 Imaging System (X-ray) and Surgical Navigation Systems.
• Performed reviews of Software Source Code, Hazard Analysis, Safety/Risk Assessments, PFMEAs / DFMEAs / FMEAs, and Gap Analysis of DHF and DHRs. Reviewed product compliance with FDA guidance on Cybersecurity and EU's Annex 11 for computerized systems. Revised current and developed new SOPs and templates for Software Quality documentation.

Validation Engineer (for Software and Hardware)

Confidential, Ann Arbor, Michigan

Responsibilities:

• Wrote and executed Test Method Validations, Engineering Studies, Sterilization and Packaging Validation as part of a remediation project for the cardio-vascular medical devices and accessories. Pre-reviewed other team members’ documents.
• Developed SOPs, document templates and forms for the test method validation documentation.

Validation Engineer (for Software and Hardware)

Confidential, Hudson, New Hampshire

Responsibilities:

• Wrote Process Validation documentation (e.g., Engineering Studies, Test Method Validations, Installation Qualifications, Operational Qualifications and Process Qualifications, and statistical analysis of the resulting TMV/OQ/PQ data). Executed Process Validation on equipment and processes (which included vision, automated and manual systems) used to manufacture medical device products, including Thoracic Chest Drains and associated accessories.
• Wrote Packaging and Sterilization Validations and Aging Study documentation for numerous products. Performed Standards Compliance Reviews for documentation for multiple devices and updated as needed.
• Performed Gap Analysis of DHF for multiple medical devices/products. Remediated DHF by updating or generating missing documentation. Updated DHF Index to reflect most current information. Updating Risk Management Files.

Quality Engineer (for Software and Hardware)

Confidential, Plano, Texas

Responsibilities:

• Reviewed and approved Engineering Change Orders for all types of DHF documentation for hardware and software (Requirement & Designs Specifications, Drawings, Verification/Validation, Risk Management, Labeling to include IFUs, DFUs, and applied labels in English and non-English languages) for medical devices such as IPGs (Internal Pulse Generators) (neurostimulators), Confidential t and Clinician Programmers, Chargers and other associated accessories.
• Team member representing QA contributing towards IEC 60601-1 3rd Edition compliance projects, and towards CE s projects, which includes reviewing and remediate documentation necessary for CE . Particularly involved with insuring RMF (including FMECAs, Traces, Risk Management Summary Reports) was compliant with international standards and regulations.

System Engineer (for Software and Hardware)

Confidential, Chicago, Illinois

Responsibilities:

• Wrote, executed Verification and Validation documentation, which included new requirements for IEC 60601-1 3rd Ed compliance for the CDI 500 Blood Monitoring System, both on the hardware and software.
• Reviewed and Approved project quality documentation. Designed Verification/Validation test protocols and report templates.
• Created Trace Matrices of requirement to validation documentation through DOORS.

System Quality Engineer

Confidential, Indianola, Pennsylvania

Responsibilities:

• Performed gap analysis and remediation work on legacy product (Infusion Pumps and MR eCoil Imaging Systems), which included accessing gaps and remediating/updating Design, Application and Software FMECAs, Risk Management Plans and Reports, and ensuring DHF and DHF Index reflected required updated documentation.
• Reviewed and approved quality documentation.

Senior Software Quality/Verification Engineer

Confidential, Boulder, Colorado

Responsibilities:

• Wrote documentation for Proof-of-Concept verification on concept development of new ablation system peristaltic open-irrigation pump and compatible tubing system set based on client’s specifications. Wrote documentation for formal design development stage Verification/Validation on this pump system.
• Performed Risk Management activities (developed and documented System Risk Analysis, FMEAs (Design, Application, Software and Process), and Fault Tree Analysis). Wrote accompanying documentation (Risk Management Plan, Summary and Report). Reviewed and Verified compliance with quality system. Updated DHF and DHF Index.

Quality Data Systems/Software Quality Engineer (for Software and Hardware)

Confidential, Englewood, Colorado

Responsibilities:

• Performed data mining and data infrastructure system/business analysis of company-wide quality systems. Developed both high and low-level documentation (including schemas, flow diagrams, data dictionaries) for related system databases and processes. Performed periodic Gap Analysis of DHF and DHF Index and remediated any deficiencies.
• Developed manufacturing capacity and other statistical reports from data in MS SQL Server using Report Builder, utilizing tag-data downloaded from PLCs on the automated manufacturing bag and needle machines.
• Performed ladder-logic software code, technical and requirement reviews for Allen-Bradley PLCs on the automated manufacturing machines.

System Verification/Validation Engineer (for Hardware)

Confidential, Minnetonka, Minnesota

Responsibilities:

• Reviewed and documented manufacturing processes and equipment. Performed Process Characteristics, DOE studies and Data Mining regarding the tensile strength and welding of platinum rings to ablation type catheters used for atrial fibrillation, using various programs including Minitab for statistical analysis.
• Designed new single universal tool adapter which could be used to more efficiently test tensile strength of welds on the various tensile testing equipment located on the manufacturing floor. Previously this required access to multiple adapters.
• Validated manufacturing processes for various types of catheters manufactured at site. Reviewed Process Validation processes and procedures and updated as needed. Wrote required Process and Design Validation documentation and reports. Executed test protocols. Conducted Site Inventory. Gap Analyzed and Remediated DHF and updated DHF Index.

Senior Business Process Analyst (for Software)

Confidential, Fremont, California

Responsibilities:

• Conducted and documented validation gap analyses of legacy medical device manufacturing process equipment, automated systems, and quality systems, including spreadsheets.Remediated gaps by writing required validation documentation and reports. Executed test protocols. Baselined software of medical device manufacturing process equipment and quality systems.

System Verification/Validation Engineer (for Software and Hardware)

Confidential

Responsibilities:

• Provided Process Validation expertise on medical device manufacturing, including catheters, sutures, pleural-evac systems, and circuit respiratory devices. Reviewed/verified instrument calibration processes.
• Conducted site inventory. Qualified and validated (IQ, OQ and PQ) medical manufacturing equipment and processes, which included extruders, injection molding machines, CNC lathes, ultrasonic welders, UV welders, packaging machines and printers, silk screen color printers, lathes, ovens, heat bar sealers, and tubing corrugators.

System Verification/Validation Engineer (for Software)

Confidential, Lawrence, Massachusetts

Responsibilities:

• Wrote User/System Requirements and System Verification Protocols for Surgical Navigation and Intra-Operative Imaging Systems. Validated to HIPPA compliance. Base-lined software and documentation.
• Tracked/resolved discrepancies. Produced statistical/analytical data reports. Performed code reviews. Contributed to the successful effort to resolve issues regarding their FDA Consent Decree, which was lifted May 2008.

Software Quality Engineer (for Software)

Confidential, Maple Grove, Minnesota

Responsibilities:

• Provided software quality support and leadership for multiple manufacturing and automation development projects, specifically for balloon angioplasty devices, stents and stent delivery systems, as well as catheters. Performed quality and code reviews on life-cycle deliverables for technical correctness and procedural requirements.
• Provided expertise, guidance and in process/design verification methods and strategies to project teams according to site/project-specific verification SOPs. Ensured compliance with domestic/international regulations and standards.

Software Quality Engineer/Business Analyst/Systems Analyst/Project Manager (for Software)

Confidential, Lakewood, Colorado

Responsibilities:

• Managed and monitored progress of projects and coordinated between software development teams, project engineers, end-users, and management to ensure efficient and effective progress of projects.
• Analyzed enterprise systems, gathered and documented user/system requirements and processes. Created Use Cases, tested and managed implementation of new software systems. Developed continuous improvement plans and processes. Performed periodic Gap Analysis of DHF and DHF Index and remediated any deficiencies.
• Verified and validated software and hardware (Design Verification and Process Validation) for dialysis machines, blood component systems, peripheral equipment, and water treatment systems.
• Performed Root Cause Analysis and managed/ resolved CAPA issues related to servicing dialysis machines and blood component equipment.
• Developed material, determined requirements, and trained 300+ users on enterprise software and Microsoft Office software used to record service and repair activities. Re-trained current users to maximize knowledge-base.