Technical Writer, Medical Device
EnsoData
full-time
Posted on:
Location Type: Hybrid
Location: Madison • Wisconsin • 🇺🇸 United States
Visit company websiteSalary
💰 $85,000 - $95,000 per year
Job Level
Mid-LevelSenior
About the role
- Author, edit, and manage user documentation based on features in releases and request for customer-facing documentation including, but not limited to:
- User manuals, reference guides, instructions for use (IFUs), and release notes
- Customer application notes/technical tips
- White papers
- Creates, develops, plans, writes and edits operational and instructional documents for paper or online publication, or multimedia or web-based deliverables.
- Ensure documentation is clear, consistent, version-controlled, traceable, and conforms to the company documentation and quality system standards.
- Support documentation needs for regulatory submissions and audits (e.g., FDA, ISO).
- Maintain document control practices beyond the user documentation and for quality management system processes and records including review cycles, approvals, and archiving.
- Work closely with Engineering, Product, Quality, Regulatory, Clinical, and Customer teams to gather requirements and technical input; SME of customer-facing documentation and related regulatory compliance.
- Translate engineering and clinical concepts into structured, user-appropriate documentation.
- Reviews internal project documentation and participates as part of the product release team.
- Assist with customer-facing training materials such as writing, editing of drafts, and potentially help generate video.
- Interact with devices to determine functionality and work with internal clinical and support personnel on intended workflow(s).
- Help standardize documentation templates, style guides, and best practices.
- Improve documentation workflows to support scalability as the company grows.
- Identify gaps or inconsistencies and proactively recommend improvements.
- Recommends formats responsive to technical and customer requirements.
Requirements
- Bachelor's degree in English/Communications or equivalent years of work experience
- 5+ years as a technical writer for software-based medical device or highly regulated products
- Experience in healthcare or medical device industries is preferred
- Direct experience with FDA QSR, ISO 13485:2016, EN 1041, and labeling related regulations and standards preferred
- Experience with formal user documentation (label/labeling) processes and multiple output generation from a single-source
- Previous experience at startup, tech, software engineering, or similar company
- Knowledge of Macintosh operating system desired
- Skilled with Adobe products, preferably Framemaker and/or Robohelp
- Expertise with MS Word and Google Docs
- Competent in Atlassian products (Jira, Confluence, BitBucket)
- Familiar with browser-based help systems
- Knowledge of user documentation formats
Benefits
- Hybrid/Remote Company - we are a company with hybrid and remote options. That being said, we have an amazing office headquarters in downtown Madison, WI with views of the capitol that you are welcome to work from at anytime. In case you didn't know, Madison has consistently been ranked as one of the top places to live in the US (businessinsider.com, money.com, livability.com)!
- Health, dental, and vision insurance with options to choose a plan that fits you and your dependents needs.
- Paid time off options - we want our employees to rest, recharge, and feel better.
- Stock options - we want team members to feel ownership in the organization. When EnsoData does well, you do well.
- Company Bonus Program - if we do well, we want to reward our team members! This position may include participation in the company bonus program.
- 401k to help people invest in the future.
- Team Summits! We look forward to opportunities to gather in person and enjoy a few days together. We participate in team events and gain some great in-person time. (Hint: check out our blog for info from former team gatherings!)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
technical writinguser documentationdocument controlregulatory compliancequality managementcontent developmenteditinginstructional designmultimedia documentationformatting
Soft skills
communicationcollaborationattention to detailproblem-solvingorganizational skillsproactive improvementadaptabilitycustomer focusteamworkcreativity
Certifications
Bachelor's degree in EnglishBachelor's degree in CommunicationsISO 13485:2016 knowledgeFDA QSR knowledge