Erica Kaltenbock

***** ******* *****

Pittsburgh, PA 15235

412-***-****

ac9aqn@r.postjobfree.com

PERSONAL SUMMARY

An experienced & educated technical communicator / visual designer with extensive background in electronics and medical device engineering

SKILLS SUMMARY

Procedure and Instruction Writing

Content Layout

Visual Design and Illustration

Process Design and Improvement

Medical Device Labeling

Proposal and Business Writing

Microsoft Office and Adobe Creative Cloud

WORK EXPERIENCE

Technical Communication Specialist / Labeling Coordinator

Smith & Nephew Robotics, Pittsburgh, PA

August 2018 - Present

Developing labeling and manual design descriptions for the purpose of labeling V&V

Organizing cross-functional team meetings to identify and review weekly labeling initiatives

Laying out content and images for manuals, IFUs, and other medical device labeling

Working with translation vendors to acquire timely translations of labeling content

Reviewing revisions of medical device labeling content as part of the labeling team

Technical Writer (Contractor)

Intervala, LLC. (Aerotek), East Pittsburgh, PA

June 2017 - August 2018

Documenting, writing, and editing instructions for over 150+ printed circuit board assemblies

Developing 1st manual of style to standardize creation of assembly instructions

Developing and improving assembly processes for through-hole assembly operations

Creating and processing of internal change requests (ICR) to generate engineering changes

Interpreting drawings, target sheets, and previous document revisions to obtain information

Creating custom graphics and visual aids to immediately convey integral assembly concepts

Full-Time Student

DeVry University, Cincinnati, OH

July 2014 - October 2017

Developing and enhancing the core competencies required for technical communication

Technical Writer

TMG Electronics, Cheswick, PA

January 2012 – August 2014

Wrote and maintained assembly instructions utilized by four (4) production departments

Wrote and revised over 20 standard operating procedures for Quality Management System

Coordinated with production personnel and identified process improvements for 20+ assemblies

Maintained device records in database for all updated assembly related documentation, including drawing and instruction revisions

Researched and developed soft wall cleanroom procedures for construction and utilization of medical device assembly cleanroom

Developed V&V and risk management protocols for two (2) medical device assemblies

Internal Auditor

Performed ISO audits for six (6) departments in accordance with medical ISO 13485 standards

Electronic Assembler/ Quality Inspector

Assembled, repaired and inspected circuit boards in four (4) departments; 2000+ units per shift

Quality Inspector I

Zoll, Blawnox, PA

January 2011 – November 2011

Inspected wearable defibrillator vests for defects, examining over 45 units per shift

Recorded unit inspection history in database in accordance with company procedures

Examined devices for identical lot numbers on Bill of Materials containing 20 listed components

Identified discrepancies between Bill of Materials and engineering drawings/ schematics

Trained three (3) new inspectors in procedures related to Quality Inspector I position

Group Leader Assistant

Millennia Group, Cheswick, PA

January 2009 – August 2010

Created an Excel formula to automatically compute manually entered employee labor times

Collecting and processing employee labor reports and time sheets

Filling parts requisitions and expediting assembly parts from storeroom to production floor

Designing internal documents such as time sheets and data tracking spreadsheets

Process Writer

Transportation Control Systems, Inc., Verona, PA

May 2006 – August 2008

Created and maintained all in-house manufacturing instructions for upwards of ten (10) assemblies for customer contracts such as Bombardier and Alstom

Developed company website using web design tools, tutorials, and basic HTML knowledge

Assisted front office with RFQs (request for quotes), purchase orders, and accounts payable

Utilized Access database for inventory control purposes

EDUCATION & TRAINING

Bachelor of Science in Technical Communications

DeVry University Cincinnati, OH October 2017

Magna Cum Laude

3.78/4.00 GPA

ISO Audit Training

Regulatory and Quality Solutions Monroeville, PA May 2013

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