SUMMARY

• Skilled in medical device written materials, mechanical and electrical fields.
• Researched and developed all engineering documentation from Design Input through Design Transfer. Detail oriented, problem solver, enjoy challenges, conscientious, efficient / simplify tasks, flexible and work in a variety of departments, if necessary, to reduce company expenses.

TECHNICAL SKILLS

• All Medical Laboratory Instrumentation
• Computer Automated Machinery
• Electromechanical Test Fixtures
• Oscilloscopes
• Power Amplifiers
• Programmable Logic Controllers
• RF Generators
• Serial Port Analyzers
• Servo and Stepper Motors
• Volt Meters
• Privileged
• APPLICATIONS & DATABASES
• Adobe Acrobat DC
• Emergency Response Guides
• End User Instruction Cards
• Engineering Operation Manuals
• Engineering Technical Manuals
• IT - Operations Server Manuals
• Quality Systems Manuals
• Quick Reference Guides
• Startup/Shutdown Procedure Cards
• System Operation Manuals

PROFESSIONAL EXPERIENCE

Technical Writer, Quality Engineering

Confidential, Irvine, California

Responsibilities:

• Use Adobe Dreamweaver CC for Web edit and design for on-line User Help Manual
• Create, Edit, Revise all Design Control documentation for medical division
• Revise Test Engineering Policies for current projects
• Create SDLC documents, forms, Protocols, Reports for medical division
• Research Requirements for Software implementation medical & non-medical
• Create, Edit, Revise all documentation associated with Apollo Project when requested
• Create, Edit, and Revise all engineering documentation as requested.
• Work with SMEs for detailed requirements in associated documentation

Technical Writer, Quality Engineering

Confidential . -California

Responsibilities:

• Provide Audit Gap Analysis and Conformity Plan for company conformance and Regulatory compliance
• Create new SOPs Confidential ased on Audit findings
• Create Employee Training plan and Training Effectiveness monitoring for new SOPs.
• Revise all company documentation and Quality System corporate structure processes for Regulatory compliance
• Write and Develop Procedures from Federal requirements for Nevada Health Care Systems & Infrastructure Configuration with use of SDLC requirements
• Write Operational and Maintenance Procedures for Nevada Health Care computer systems
• Source Federal Requirements and Subject Matter Experts for Technical Input to computer systems

Quality Engineer, Technical Writer

Confidential, California

Responsibilities:

• Conducted Design Control meetings for acknowledgement and Design Phase sign-off
• Assisted in troubleshooting manufacturing machinery issues with co-workers
• Conducted Risk Analysis for new products
• Wrote and performed Manufacturing Audits
• Wrote Test Method Verification and Validation processes and reports, Process Instructions, and Equipment Operation Instructions
• Updated Engineering Drawings
• Created graphics and layouts for Marketing materials and System Operator’s Manuals

Technical Writer, Engineering

Confidential Irvine, California

Responsibilities:

• Operated machinery to complement creation of operational instructions
• Used Confidential .Docs for creating, tracking, updating and revising all engineering documentation
• Developed individual machinery operation process flowcharts for complete systems automation
• Created in-depth graphic design product logo for company project use
• Wrote and executed manufacturing audits, process instructions, and equipment operation instructions
• Wrote Test Method Verification and Validation processes and reports
• Developed product labels, IFUs and electronics test instructions
• Used Windchill for tracking, updating and revising engineering documentation
• Developed Quality Assurance procedures for RF Generator testing

Technical Writer, Engineering

Confidential . - Northridge, California

Responsibilities:

• Used SolidWorks and AutoCAD 2010 for drawing revisions
• Created Graphics and Illustrations for computer automated processes
• Used SAP documentation database for all company documentation
• Worked with Manufacturing and R&D Engineering to create applicable project documentation
• Performed Design Planning in Microsoft Project
• Restructured Company Risk Management for Class III Medical Device from IEC-812 FMECA to ISO 14971:2007
• Created Risk Management process Training Guides
• Developed new Risk Management Work Instructions for creation of the company Risk Management structure and compliance
• Assisted Manufacturing Engineering staff with processes and procedures for upcoming projects
• Worked with Quality Assurance in CAPA research and specific documentation related to product development
• Assisted Clinical and Regulatory on Clinical Risk Assessment worksheets
• Worked with R&D Engineering on scheduled projects

Technical Writer, Validation & Verification Engineering

Confidential - Santa Ana, California

Responsibilities:

• Critiqued the technical writing team to verify proper content and format of sub-systems test protocols for the phacoemulsification system
• Wrote Validation & Verification Test procedures, reports, and testing criteria for phacoemulsification systems
• Wrote Work Instructions for Validation Engineers when testing software and firmware.
• Created testing diagrams and design graphic illustrations for test instrumentation used in Validation testing

Technical Writer, Product Support Engineering

Confidential - Irvine, California

Responsibilities:

• Developed troubleshooting guides
• Developed problem solving guides on instrumentation sub-system mechanisms
• Assisted in product awareness to decrease product defects and increase Product Reliability
• Wrote Technical Training guides and Service Confidential ulletins for Field Service Engineers
• Used Adobe Professional Publications Software for FDA, CLIA and CLSI compliancy
• Trained engineers on System Operations, maintenance and electromechanical troubleshooting
• Wrote User and Technical Manuals, Quick Reference Guides, Instructions for Use
• Established laboratory instrumentation guidelines for Hematology Quality Control