Howard Goldman
Irvine, CA
currently: Job hunting
|
Work history
Sr. temp. technical-medical writer
tags:
word; qa procedures based on ...
How would you describe your time at XCORPOREAL CORP., Irvine, C...?
Writing and editing SOPs, specifications, publications, protocol, hazard analysis reports, and user guides for portable artificial kidney.
* Standard Operating Procedures (SOPs):
- Drawing Control
- Quality Records Retention
- Material Control
- First Article Inspection
- Non-conformance
- Supplier Approval
- Purchasing
- Shipping and Receiving
- Returned Goods
- Internal Audit
- Preventive Maintenance
- Supplier Audit
* Specifications
- Market Requirements Specification: Portable Artificial Kidney
- Product Specifications: Portable Artificial Kidney
* Publication: The Xcorporeal Sorbent Cartridge for Dialysate Regeneration in Kidney Dialysis
* Protocol for Hemolysis Testing of Pump Mechanisms... 
Sr temp technical-medical QA writer
tags:
writer & editor: qa and compl...
How would you describe your time at CAMERON HEALTH, INC., San C...?
Wrote and edited the following technical documents for Quality Assurance on subcutaneous implantable cardiac monitors, pacemakers, and defibrillators:
* Policies, Procedures, and Work Instructions (WI)
- Risk Management
- Corrective and Preventive Action (CAPA)
- Complaint Handling
- Software Risk Assessment
- Quality Policy Manual
- How to Prepare a Risk Analysis
- Quality Planning
- Quality Management Review
- Training
- How to Prepare a Failure Modes and Effects Analysis (FMEA)
- Product Change Board Operations
- Agency Visits
- Handling Quality System Audits by External Parties
* These documents were based on following standards and regulations:
- 21 CFR 820 FDA Quality System Regulations for Medical Devices.
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices (U.S. Dept. of Health and Human Services, FDA, CDRH, Office of Device Evaluation).
- ISO 13485 Quality Management Standard for Medical Devices and Related Services.
- ISO 14971 Medical Devices: Application of Risk Management to Medical Devices.
- ISO 9001 Quality Management, Quality Manual, Quality Procedure, Internal Quality Audit.
- ISO 9000-3 Quality Management Standard for Computer Software.
- ISO 10993-1 Biological Evaluation of Medical Devices: Evaluation and Testing, etc.
- ISO 14969 Medical Devices Quality Management Systems Guidance on the Application of ISO 13485:2003.
- IEC 60300-3-9 Dependability Management-Part 3: Application Guide-Section 9: Risk Analysis of Technological Systems.
- IEC/TR 60513 Fundamental Aspects of Safety Standards for Medical Electrical Equipment.
- IEC 60601-1-4 Medical Electrical Equipment Part 1: General Requirements for Safety. Part 4. Programmable Electrical Medical Systems.
- IEC 60812 Analysis Techniques for System Reliability - Procedures for Failure Mode and Effects Analysis (FMEA) and Failure Mode, Effects and Criticality Analysis.
- IEC 61025 Fault Tree Analysis (FTA).
* Good Laboratory Procedure (GLP) Animal Study Protocol
* Spreadsheet for Tracking Requirements, Tests, and Compliance for Implantable Cardiac Device (ICD) Pulse Generator, using the following standards:
- ANSI, AAMI, International Standards Organization (ISO) 11607 Packaging for Terminally Sterilized Medical Devices
- ISO Technical Committee (TC) 150/SC Active Implantable Medical Devices (AIMD)
- British Standard (BS), Deutsches Institut f??r Normung (DIN), European Norm (EN) 45502 AIMD
- ASTM D4169 Performance Testing of Shipping Containers and Systems
* Programmer Software Requirements Specification...
Sr temp technical writer
tags:
writing andediting in word an...
How would you describe your time at QLOGIC CORP., Aliso Viejo, ...?
Created tech and marketing documentation for world-leading supplier of fibre channel (FC) host bus adapters (HBA), blade server embedded and stackable FC switches, fabric switches, controller chips, and iSCSI HBAs. These products powered Storage Area Network (SAN) solutions for Cisco, Dell, EMC, Hitachi, Data Systems, HP, IBM, NEC, Network Appliances, and Sun Microsystems.
* Wrote and edited technical and marketing documents in Word and FrameMaker
* White papers
* Readme files and release notes
* Tech Pubs Style Guide and Procedures...
Sr temp technical writer
tags:
sw test documentation using word
• clearcase
• doors document and revision c...
• adobe acrobat
How would you describe your time at BOEING AIRCRAFT CORP., Long...?
Writing and editing software-test documentation at Boeing???s Software Engineering Environment (SEE) group, for Air Force C-17 cargo plane.
* Worked closely with Boeing software engineers, technicians, and customers:
-Air Force System Program Office (SPO)
-Defense Contract Management Agency (DCMA)
-Achieving acceptance of all my documents.
* Wrote procedures and checklist for writing and editing Software Engineering Environment documents.
-Achieving compliance with all government documentation regulations
-Making the production of documentation organized, efficient, complete, and successful.
* Provided independent review of 4,000 pages of Boeing documents.
* Organized and conducted effective Peer Review meetings with Air Force representatives.
* Edited and reviewed the following document types:
- Software test plans (STP and CPTPL)
- Procedures (CPTPR)
- Specifications
- Software test reports (STR)
- Software test descriptions (STD)
* Wrote about the following systems:
- Hydraulic System Computer (HSC)
- Load-Forward Control Panel (LFCP)
- Mission/Communication Keyboard (MCK)
- Aircraft Propulsion and Data Management Computer (APDMC)
- Multi-Function Display (MFD)
- Heads-Up Display (HUD)
- Caution Aural Warning System (CAWS)
- Warning and Caution Computer (WCC)
- Warning Annunciation Panel (WAP)
* Wrote and edited to MIL-STD-498 and MIL-STD-1553....
Sr temp technical writer
tags:
writing and editing risk-mgt ...
How would you describe your time at ALCON LABORATORIES Irvine ...?
Documenting medical device R&D for ophthalmic surgical lasers and endoilluminators.
* Timely writing and editing of documents instrumental in Alcon???s maintenance of ISO certification:
- Risk-Management Report for EyeLite?? Laser System, used to treat proliferative diabetic retinopathy, macular degeneration, and retinal detachment.
- Risk-Management Report for ACCURUS?? High Brightness Illuminator (AHBI), for illuminating the interior of the eye during surgery.
- EyeLite?? Laser Hazards and Harms.
- Protocol for EyeLite?? Laser Clinical Literature Survey (CLS).
* Wrote in compliance with the following standards, rules, and regulations:
- Good Manufacturing Practices (GMP).
- Good Clinical Practices (GCP).
- Good Laboratory Practices (GLP).
- Predicate Rules (both FDA Act and Public Health Service Act).
- Codes of Federal Regulations (CFRs, such as 21CFR Part 11).
- ISO 15752: 2000 (Ophthalmic Instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety).
- IEC 60601-1: (Medical electrical equipment, Part 1: General requirements for safety).
* Edited articles, such as ???Thermal Study of Bare Ultrasound Tips with Various System Parameters and Incision Sizes,??? for publication in Journal of Cataract and Refractive Surgery.
* Worked with IT, Regulatory, and QA....
Sr temp technical and mktg writer
tags:
writing and editing in word
• photography
• illustrator
• draw
How would you describe your time at MARVIN TEST SYSTEMS/GEOTEST...?
Wrote, edited, illustrated, photographed, and formatted the following:
* 400-page technical, maintenance, installation, and operation manual for Raytheon missile test station.
* Built successful team with top management, engineers, technicians, graphic artist, and IT.
* Met tight customer deadline using MS Word, PhotoShop, and Draw (graphics)....
Sr technical and marketing proposal writer
tags:
writing and editing tech and ...
How would you describe your time at ARGO-TECH CRYOGENICS, J.C. ...?
In Costa Mesa, CA, via temp agency, wrote, edited, illustrated, proofread, and took digital photos for proposals, product descriptions, procedures, manuals, journal articles for pumps that move liquefied gasses to and from tanker ships.
* Edited and proofread successful proposals to Halliburton-KBR (Kellogg, Brown & Root), Bechtel, Samsung, Korea Gas, and Chicago Bridge and Iron (CB&I).
* Built effective teams with development, support, and project management....
SR TEMP TECHNICAL PROCEDURE WRITER
tags:
writing and editing procedure...
How would you describe your time at CORNING, INC.: ADVANCED PHO...?
Located in Stanton, Cypress, and Fountain Valley, CA, via Escoe-Bliss agency:
* Saved Corning and Samsung $100K by researching the reason for components coming unglued.
* Wrote, edited, and illustrated over 200 optics and fiberoptics assembly, configuration, installation, and support procedures and specifications, patent applications, and presentations.
* Built teams with development, support, and project management at Corning???s APT and OND facilities.
* Provided assistance and guidance to other staff in writing, editing, and MS Word....
Sr temp technical writer, editor, proofreader
tags:
framemaker
• maint.
• user guides in ms word
How would you describe your time at PAIRGAIN TECHNOLOGIES, opti...?
Via temp agency, edited, updated, formatted, and proofread hardware and software installation procedures and configuration, maintenance, and user guides.
* Worked in standard templates and formats in MS Word and FrameMaker.
* Did proofreading in Spanish, Brazilian Portuguese, and English.
Sr temp technical writer, editor, proofreader
tags:
specs using ms office
• manuals
• hw sw
How would you describe your time at PRINTRAK INTERNATIONAL, Ora...?
Image-processing hardware and software for automated fingerprint storage and identification.
* Edited and formatted engineering plans and configuration, installation, maintenance, and user guides.
* Used standard templates and formats in FrameMaker and Word.
Sr temp technical/medical/Information-Mapping Writer
tags:
information mapping
• procedures
• engineering change order (eco)
How would you describe your time at BAXTER/EDWARDS HEALTHCARE (...?
Paced by temp agency, in Irvine, CA:
* Process flow and procedures in MS Word.
* Information Mapping for Engineering Change Order (ECO) procedures.
Sr temp technical writer
tags:
writing
• ms word.
• configuration and user guides
• editing
How would you describe your time at TOSHIBA AMERICA INFORMATION...?
In Irvine, CA, via temp agency:
Updated configuration and user guides for notebook computers.
* Increased document turn-around time by 30%.
* Provided assistance and guidance to other staff in writing, editing, and MS Word.
Education
PhD in literature, linguistics, and area studies
tags:
assistantships
• fellowships
How would you describe your time at indiana university, bloomin...?
* Additional graduate work in economics, sociology, and politics for certificate in area studies.
* National Graduate Honor Society.
* National Defense Fellowships.
* Assistantships for research and teaching.
- Researched and edited books for Indiana University Press.
- Wrote five articles for ???Columbia Dictionary of Modern European Literature??? (N.Y.: Columbia University Press)....
MA in literature and linguistics.
tags:
assistantships
• fellowships
How would you describe your time at Cornell University, Ithaca,...?
* New York State College Teachers Fellowship.
* National Defense Fellowships.
* Research Assistantships: book research and editing.
BA in linguistics and science
tags:
scholarships for science and ...
• dean's list
How would you describe your time at Cornell University, Ithaca, NY?
* Dean's Honor List.
* Cornell University Scholarship.
* New York State Regents Math, Science, and Engineering Scholarship.
* New York State Regents College Scholarship.
* Acacia Fraternity scholarship.
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