Technical Writer Medical Device

PROFESSIONAL SUMMARY

Multifaceted Senior Technical Writer with 15+ years of experience developing user-centered and compliance documentation in the finance, banking, medical device, healthcare, and technology sectors. Proven track record in creating SOPs, IFUs, release notes, user manuals, training content, and knowledge management systems aligned with FDA and ISO standards. Tracked compliance in finance and surgery.

CORE COMPETENCIES

Technical Documentation & Editing

FDA/ISO medical device compliance (21 CFR 820, ISO 13485, 9001, 14971)

SOPs, IFUs, UX Writing, Help Systems

Knowledge Management (SharePoint, ServiceNow, AWS)

Tools: Windchill, InDesign, Oxygen, XML, HTML, css, Codebeamer, Photoshop, FrameMaker, Word, RoboHelp, Dreamweaver, MadCap

Agile/Scrum/SDLC Methodology

Visual Communication, Training, Instructional Design

EXPERIENCE

Knowledge Management Writer

TriWest Healthcare Alliance, Phoenix, AZ — 09/2024–Present

Authored 300+ customer service and training documents supporting DOD, DHA, and VA implementation.

Streamlined scripting content and FAQs using SharePoint, AWS, HTML, and ServiceNow.

Collaborated cross-functionally to ensure seamless app deployment and operational efficiency.

Senior Content Developer

Terumo BCT, Lakewood, CO — 09/2023–07/2024

Created thousands of pages of technical documentation for blood/cell/plasma devices.

Tools: Windchill, InDesign, Illustrator, Oxygen, Photoshop, XML.

Supported documentation of V&V, IFUs, and user manuals under tight deadlines.

Technical Writer

Remarque Systems, Morrisville, NC — 06/2022–09/2023

Produced clinical trial software user documentation including graphics and screen markups.

Collaborated with SMEs to deliver user-focused materials.

Senior Technical Writer

Sentera, Saint Paul, MN — 01/2020–05/2022

Authored AI drone documentation for precision agriculture, using face recognition and GIS capabilities on pests and weeds.

Designed new web site, created voice-over videos, web content, and Zendesk help systems.

Developed API-integrated content management strategies.

QA Test Specialist

Medtronic/Blue Sages, Fridley, MN — 11/2019–12/2019

Developed test plans and executed firmware tests for urinary medical device.

Tools: Oscilloscope, Codebeamer, digital meters.

Design Labeling Engineer

Verb Surgical (Google & Johnson+Johnson), Mountain View, CA — 04/2019–11/2019

Led technical writing team for surgical robotic start-up.

Authored SOPs, DPs, and protocol documentation to FDA standards.

Trained engineers on documentation standards.

Business Systems Analyst

Wells Fargo, St. Louis Park, MN — 07/2018–04/2019

Tracked and rewrote SDLC compliance policies; maintained BRD, SRS, and TRD.

Tools: JIRA, Documentum, SharePoint, Scrum methods.

Design Labeling Engineer

Medtronic/Blue Sages, Fridley, MN — 02/2016–07/2018

Led documentation for Neuromodulation and Patient Care Medical Devices for spine and brain stimulation and medication for embedded firmware, software, system, mechanical, electrical, requirements, testing engineers. Led doc efforts on Mobile Device Management team to create app-based patient neuro care.

Created ISO/FDA-compliant templates, DHFs, ECOs, ECR, BOM, SDD, V&V, CAPA, DFMEA, DMR.

Assisted with code quality testing, C++, C.

Tools: Codebeamer, eNovia, Windchill, Access, content management, Documentum, Rational ClearQuest, LabWare, Requisite Pro, Spotfire.

CREATIVE PROJECTS

Visual Artist & Instructor

Kris Lange Art, The Villages, FL — 10/2017–Present

Delivered acrylic and watercolor art instruction.

Owned retail business. Planned art events.

Created and managed e-commerce website, SEO, newsletter, email marketing.

Developed MS Access database for business tracking and marketing.

Tools: CapCut, YouTube, Photoshop, WordPress, Wix, Square, ChatGPT, WordPress, social media.

Art Teacher

People Incorporated Mental Health Services, Minneapolis, MN — 01/2023–06/2023

Taught acrylic and watercolor techniques to disabled children and adults.

Selected Creative Projects:

Designed book cover for best-selling author. Led QR code workshops for artists.

Produced Kentucky Derby web series at Land O’Lakes; picked up by national news outlets.

PAST HIGHLIGHTS

Saved $100K+ by streamlining online help UX C++ content at US Bank.

Resolved 5,000+ RoboHelp errors; consolidated 6,000 help topics at NSP.

Led offshore team to convert 500 Word docs to 508 compliant FrameMaker SaaS/Cloud files at Oracle.

Spearheaded documentation for mobile neuro-care app at Medtronic.

Designed Word template to streamline process at Medtronic.

Repaired strained relationship between writing and development teams at Oracle.

Converted over 15 Fortune 500 companies into clients through sales presentations for Spherion.

Doubled the size of the newspaper in less than 3 years at Sawyer County Record.

Instrumental in starting award-winning North Iowa Farmer monthly insert for the Globe Gazette.

B.S., Technical Communication / Animal Science Journalism University of Minnesota

Design Labeling Engineer certificate

SharePoint User certificate

Security Clearance: NACI Tier 1 — Dept. of Defense ID #163*******

Contact this candidate