SUMMARY:

• Documentation / Publications: Hardware & Software End User & Engineering documentation; Technical Manuals including; Installation & Configuration, Set - up & Operation, System Administration & Provisioning, Preventative Maintenance, Troubleshooting & Repair guides; online Help systems (Web-based, Context -sensitive); standard operating procedures (SOP); Work Instructions; request for information (RFI) documentation; policies, procedural, and instructional documentation; Computer System Validation (CSV) documentation; instructions for use (IFU); process guidelines; manufacturing procedures; device history files (DHF); equipment history files (EHF); installation qualifications; traceability matrix; Impact Assessments; HTML templates; e-Learning modules, curricula and materials; instructor guides; application programming interface (API) guides; software / hardware guides; User & Functional Requirements Specifications; Software Design (SDS), Non-functional Technical Requirements; Data Sheets; Enterprise Architecture Summaries; Marketing collateral and sales enablement materials; Application Catalogs; Process & Workflow Maps; Data Flow Diagrams; FAQs; Quick Start guides; Video scripts; Video tutorials; Release Notes

TECHNICAL SKILLS:

Documentation Tools: Adobe FrameMaker; MS Office Suite (Word, Visio, PowerPoint, Excel, Project); Macromedia RoboHelp; SharePoint Designer 2010; MS InfoPath 2007; Adobe Captivate; Adobe Creative Suite/Cloud; Macromedia Dreamweaver; Adobe Acrobat; Adobe Professional; MS Project; MS Sharepoint; HTML coding / editors / tools; Snag-it screen capture utility; Adobe Illustrator; Adobe Paintshop Pro; Adobe InDesign; Quark XPress; Adobe Photoshop. Documentation Management Systems Livelink, Documentum, MasterControl & Agile PLM systems.

PROFESSIONAL EXPERIENCE:

Confidential, Billerica, MA

Senior Technical Writer

Responsibilities:

• Researched and authored Standard Operating Procedures (SOP), Work Instructions, and Process Workflows / Process Maps detailing Disaster Recovery/Business Continuity processes for corporate Enterprise Infrastructure IT systems and enterprise-wide software applications.
• Researched and wrote Architecture Summary documentation (detailing system architecture, sub systems, system integrations, and data/process workflows) for corporate IT infrastructure-related software applications, corporate systems, and other technology solutions. Created system topology and architecture models, data flow diagrams, process maps, and process workflows using the SPARX Enterprise Architect tool and MS Visio. Wrote software user guides for Enterprise Architecture modeling tools.
• Researched and wrote Hardware/Software-focused System Design specifications for SaaS applications and enterprise-class client/service software applications in an SDLC environment. Created MS Word-based templates and managed the documentation lifecycle for the Enterprise Architecture documentation repository and knowledge base.
• Created Web-based HTML / XML templates for Disaster Recovery / Business Continuity Plans using RPX content management system.
• Created and Designed MS PowerPoint presentations detailing IT processes for corporate technology solutions. Created RACI matrices for corporate IT Data Governance projects.
• Maintained and updated internal documentation catalogs, and system / software application catalogs.
• Served as consultant and advocate for good documentation practices and methodologies.

Confidential, Merrimack, NH

Senior Technical Writer

Responsibilities:

• Researched and wrote comprehensive (hardware/software-based) equipment manuals (detailing hardware/software architecture, sub systems, system integration, set-up and operation, user interface, repair and preventative maintenance, calibration, trouble-shooting, spare parts list, etc.) for electronic systems, HMI-controlled electro-mechanical manufacturing equipment; machinery, electronic equipment, and other capital equipment used in the manufacture and production of Endovascular and Vascular Grafts products in a GMP environment. Researched and wrote corresponding Manufacturing Procedures (MP) and Master Preventative Maintenance, Service manuals, and Calibration procedures, and prepared corresponding Design History File (DHF) documentation. Managed the documentation process (authoring, revision, review and finalization of documentation), and coordinated the documentation change order (DCO) process to release controlled documentation to the Agile PLM/ERP system.
• Researched and wrote equipment requirements (ER) specifications for legacy equipment and machinery used in the production of Vascular Grafts products. Worked independently and cross-functionality with subject matter experts (SMEs) and employed hands-on approach to researching equipment and related subject matter. Performed video captures of equipment process workflows and machine operation. Used Agile PLM system for documentation management and control activities.
• Supported the development of and execution of protocols to complete Equipment Acceptance Testing (EAT) on new equipment.
• Mentored and counseled engineering team members in relation to documentation best practices, documentation methodologies, and good documentation practices (GDP).
• Facilitated change orders (ECO/DCO’s) required to release controlled documentation to Agile PLM system. Maintained compliance to corporate Quality System and regulations for new processes and equipment.

Confidential, Lexington, MA

Technical Writer

Responsibilities:

• Researched and wrote software and hardware-based documentation in support of the BioStampMD & BioStampRC wireless software-driven bio-mechanical (sensors) systems. Authored software publications/documentation, Instructions for Use (IFU), User Manuals, Quick Start Guides, Installation and Configuration documentation. Authored documentation for Human Factors Engineering / Usability Testing initiatives.
• Working cross-functionality with Product Developers and Technical SMEs, researched and authored technical specifications (including hardware and graphical user interface (GUI)) for BioStampRC system including bio-sensor units, smartphone mobile software (Android platform) / hardware, and corresponding PC tablet. Worked with UX diagrams in relation to the production of documentation.
• Worked cross-functionally with Project Managers, Engineering staff, and other stake-holders to conduct needs user analyses to determine requirements for internal and external documentation intended for distribution via print, online and/or Web delivery.
• Researched and wrote Standard Operating Procedures (SOP) and Work Instructions in support of Engineering / Manufacturing processes and provided guidance in the creation of ISO 9001:2015 / FDA oriented Quality System Regulatory (QSR) processes governing product development and engineering practices.
• Worked in collaboration with Marketing team in the creation and authoring of marketing and sales enablement documentation including datasheets, fact sheets, application notes and other collaterals using Adobe Creative Suite/Cloud tools.
• Provided regulatory guidance to support pre-planning efforts for an FDA 510(K) pre-market submittal.
• Partnered with Manufacturing Engineering team and provided design input and quality control in the development of BioStampMD product labeling and product design. Partnered with Bio-Mechanical Engineers and participated in Reliability Testing and Validation initiatives.
• Designed and created MS Word 2016 templates including format and graphical design, pictures and diagrams, flow charts, and other schematic-based elements, and integrated MS Word templates into Adobe InDesign templates. Developed process workflows, process maps, and flow diagrams using MS Visio 2016.
• Wrote user task-based audio scripts governing user tasks and trouble-shooting tasks for audio-video tutorials for the BioStampMD / BioStamp RC systems.
• Created documentation plans / strategies comprising Marketing / Product / User Support / Regulatory documentation.
• Managed 3rd party Print Vendors in the production of hard-copy documents.

Confidential, Concord, MA

Software Technical Writer

Responsibilities:

• Researched and wrote software and hardware-based documentation in support of advanced Laser Phosphor Display (LPD) systems, digital workplace platform, and laser optic machinery and systems in an ISO 9001 environment. Authored and revised system installation, configuration, software and mechanical calibration, design documentation, service manuals, and other engineering-related documentation.

Confidential, Andover, MA

QA RA Analyst

Responsibilities:

• Prepared monthly reports / metrics summarizing internal / external QA RA Post Audit regulatory activities. Developed policies, procedures, and process workflows governing the corporate -wide CAPA management process. Using Lean Six Sigma Process Mapping techniques, developed process maps for procedural documentation.

Confidential, Wilmington, MA

Hardware / Software Technical Writer

Responsibilities:

• Researched and wrote end-user and software / hardware documentation, product documentation, and engineering design control documentation in support of the cloud-based Lythos intra-oral 3D Imaging system on a VMware platform in an ISO 13485 envirnoment. Reviewed and revised existing documentation to ensure accuracy, completeness, clarity, and usability. Solicited feedback from clients and stakeholders to support on-going documentation improvement initiatives.
• Wrote and updated Quality Management System (QMS) documentation detailing engineering / validation practices and assisted in the writing of Instructions for Use (IFU), technical specifications, and documentation/instructor guides for 510(K) documents for Class II medical device. Assisted with RoHS compliance activities including documentation and device labeling. Managed documentation management processes using the MasterControl document management system.
• Used JIRA Issue and Tracking system for Issue tracking, team collaboration activities, and general project management tasks.

Confidential, Hudson, NH

Senior Technical Writer

Responsibilities:

• Researched and authored detailed step-by step manufacturing procedures (MP), task-based procedural documentation, preventative maintenance & service manuals / task lists / work instructions, and standard operating procedures (SOPs) detailing preventative maintenance / repair tasks for electromechanical medical device manufacturing equipment used in the manufacture of Thoracic / Endovascular / Mesh / Grafts medical products in a GMP environment as well as Operations / Facilities equipment as part of corporate remediation initiative. Created MS Word-related templates for Preventative Maintenance procedures and Calibration / Verification procedures.
• Updated Calibration / Verification procedures for calibrated instruments and tooling equipment. Evaluated and ensured documentation adhered to cGMP and ISO regulatory guidelines. Authored documentation via a combination hands-on and collaborative approach with subject matter experts (SMEs) including Manufacturing Engineering Technicians / Engineers, Operations, Facilities, Quality Management, and Research and Development personnel.

Confidential, Lexington, MA

Senior IT Business Systems Analyst / Technical Writer

Responsibilities:

• Managed the implementation and deployment of the Web-based Enterprise Project Management (ePM) system and Microsoft Project Server 2010 across the Shire HGT SPPM organization. Served as the system administrator of the ePM/ERP system and Microsoft Project Server performing system configuration and validation / testing, trouble-shooting and remediation activities, as well as system maintenance.
• Created, developed, planned, authored, and edited process-oriented, operational, instructional documentation, materials, system administration, end-user documentation, test / validation procedures, and maintenance procedures for the ePM system. Developed and maintained a SharePoint - based Knowledge Base / Repository for the ePM system.

Software Process Analyst

Confidential

Responsibilities:

• Assigned to Software Engineering Process Group ( Confidential ) via executive decision to lead and manage technical documentation / projects in support of corporate-wide Process Improvement Projects (PIPs).
• Working across multiple business units in a Project Management capacity, coordinated and facilitated the corporate-wide system implementation / deployment of Confidential ’s electronic documentation management system (EDMS) across multiple business units. Supported the system / software validation of the EDMS system via authoring/execution of validation protocols/reports and tests on a VMware platform.
• Served as the Incident Manager for the EDMS system, gathering and developing Incident Management data for the generation of reports and metrics. Planned and developed an EDMS-specific Incident Management System and Knowledge Base for system remediation activities and IT Support.
• Assisted in the development and implementation of a corporate-wide Software Development Life Cycle (SDLC) methodology including the authoring of Standard Operating Procedures (SOPs) and for IT and Engineering teams.
• Worked cross-functionally as an Confidential Project Manager across multiple business units, and gathered internal EDMS user requirements, assisting the Project Management Organization (PMO) with the development of Requirements Specifications, Functional Use Case scenarios, and process workflows for the development of new EDMS functionality and features. Authored step-by step User Guides and Quick Start Guides for the EDMS system, tailoring documentation for business units for specific EDMS system use.
• Primary trainer for the EDMS system conducting instructor-led sessions, coaching and mentoring system users, and developing curricula,

Confidential

Senior Technical Writer / Business Analyst

Responsibilities:

• Authored software documentation, Technical Requirements / Specifications, Validation protocols, Change Management documentation, and Engineering-related software documentation in support of Interactive Voice Response (IVRS) and Interactive Web Response (IWRS) systems. Assisted Project Management organization (PMO) with the development of Requirements Specifications and Use Cases in support of IVRS / IWRS systems.
• Managed and led IVRS Engineering Process Improvement Projects (PIPs), analyzing IVRS Engineering software development procedures to identify inefficiencies and implement Engineering-related process improvements including engineering process workflows, procedural documentation, and materials.
• Authored IVRS Engineering-related Standard Operating Procedures (SOP) and Process Guidelines in support of IVRS Engineering practices and assisted in the development of the Standard Operating Procedures and Process Guidelines in support of the Software Development Life Cycle (SDLC).
• Managed IVRS Engineering-related Corrective Action Preventative Action Requests (CAPA) activities, performing root cause analysis and document remediation, working with the Confidential Quality Management group with respect to remediation efforts.
• Assisted IVRS Engineering in relation to Unit Testing and Design Assurance activities for IVRS / IWRS applications.
• Primary trainer of IVRS engineering team / management, developing new hire curriculum / guides for culturally diverse engineering team. Authored e-Learning modules for the Learning Management System (LMS).

Confidential, Boxboro, MA

Senior Technical Writer

Responsibilities:

• Authored software / hardware documentation, end user documentation, system configuration and administration, hardware / software installation, product documentation, and Sarbanes-Oxley (SOX) regulatory compliance documentation in support of C- Series and X- Series Network Security Swits (Linux platform) using Adobe Framemaker 7.1. Managed and facilitated translation of documentation and materials into multiple languages for European / Asian customers.
• Designed web-based Help systems for SecureShore and Element Management Systems - GUI-based network management systems using RoboHelp and Macromedia Dreamweaver.
• Authored Software Installation and CLI - related Configuration guides for third-party software security applications running on Crossbeam hardware. Authored end-user guides for SecureShore (Network Management System). Authored release notes for COS and XOS product releases using Adobe FrameMaker 7.1.
• Worked with Regulatory Affairs Director in the development and distribution of Sarbanes-Oxley (SOX) IT Controls documentation.

Confidential, Boston, MA

Project Manager / Software Technical Writer

Responsibilities:

• Project Manager for the internal documentation team including off-site editors and production specialists. Authored operational, configuration, and hardware installation guides using Adobe FrameMaker. 7.0. Worked cross-functionally with subject matter experts (SMEs), and authored process improvement proposals detailing improved usage of documentation source control / documentation defect system.

Confidential, Lexington, MA

Senior Documentation Writer

Responsibilities:

• Authored Web-based on-line and context-sensitive Help systems (using Functional Requirements Specifications, Use Case scenarios) for Windows-based software applications using Macromedia RoboHelp x5. Working with subject matter experts (SMEs), authored C+ and COM API guides for internal Engineering use. Developed operational, configuration, user guides, deployment guides, and end-user manuals for IT and internal Professional Services group using Adobe FrameMaker 7.0.
• Designed HTML - based Quick Start guides, Release Notes, FAQs, Read Me text documentation using MacroMedia DreamWeaver MX2004. Assisted with beta and unit testing activities, and design assurance activities.

Confidential, Marlboro, MA

Senior Technical Writer

Responsibilities:

• Authored internal IT procedural / process documentation set for SMCU Information Technologies (IT) group using Microsoft Word 2003. Used Documentum electronic documentation management control system (EDMS) for documentation versioning and archival.
• Researched and authored internal disaster recovery / business continuity plans using Microsoft Word 2003 / MS Visio.

Confidential, Melbourne, FL

Principal Technical Writer / Project Manager

Responsibilities:

• Managed documentation projects & documentation strategy using MS Project for six member off - site documentation team.
• Researched, planned, and authored single-source documentation suite for v1.0 Windows - based multi-media software applications and auxiliary product line using Adobe FrameMaker 7.0. Planned and authored HTML-based Help system using Macromedia RoboHelp 5x and Macromedia Dreamweaver MX 2004.
• Authored software architecture and development process documents. Documented requirements, analysis and design, proposed architecture, test plans, and design specifications.

Confidential, Chelmsford, MA

Senior Technical Writer

Responsibilities:

• Authored single - source hardware/software documentation for CVX 0 Multi-access switches networking product line (embedded networking software, GUI - based network management system, and system hardware) using Adobe FrameMaker 6.0. Documentation included: Command guide (proprietary C++ / UNIX script), Network Administration guide (incl. IP / VPN protocols), VOIP guide, Diagnostic / Troubleshooting guide, Event Messaging guide, Network Monitoring guide, Network Topology maps.
• Designed and developed Web-based Java J2EE- based Help system using Quadralay WebWorks Publisher. Performed C++ / UNIX - based command line interface (CLI) verification.

Confidential, Manchester, NH

Senior Technical Writer

Responsibilities:

• Developed and authored print Web-based end - user documentation for enterprise - wide business / financial software applications using Adobe FrameMaker 5.5. Developed context - sensitive online Help system detailing end - user procedures and crystal report creation using RoboHelp / RoboHelp HTML 7.0.
• Authored installation, configuration, integration, and procedural documentation. Worked with engineering and testing groups to develop API documentation. Researched and implemented migration strategy to convert legacy documentation from existing Microsoft Word templates to Adobe FrameMaker solution.

Confidential, Woburn, MA

Technical Writer

Responsibilities:

• Authored end - user documentation for ISO 9000 manufacturer of software - driven, electro-mechanical, imaging - only, explosive detection systems based on client - server platform. Developed assembly, operational, field service, configuration, and installation documentation in conjunction with manufacturing, software support and field service groups.
• Performed functional and usability testing to develop procedural,, user manuals, software testing/ diagnostic procedures, and task - oriented documentation through hands - on testing and validation, in conjunction with Research and Development, Manufacturing, and software support groups.