Technical Writer; Medical Device

Technical Writer

Hi! I'm Sigrid, the VP of Regulatory and Quality and we are looking for another great teammate to help us make healthcare better! We are seeking a highly detail-oriented person who is comfortable translating complex technical and regulatory concepts into precise, usable customer-facing documentation while operating effectively and efficiently in a fast-paced, growing company.

This position offers a flexible work environment, salary range of $85,000 - $95,000 annually along with bonus program, stock options, and generous benefits including paid time off.

Our ideal candidate will live in the Madison, WI area. We will give preference to those who have medical device experience.

Enso Data strives to make healthcare more accurate, efficient, and affordable through waveform artificial intelligence (AI) technology. Using AI and machine learning, our software analyzes billions of data points collected from sensors placed throughout the human body. Our first solution, Enso Sleep, reduces the time clinicians spend analyzing, scoring and managing sleep studies. This results in a simplified and accelerated patient testing, diagnosis, and treatment workflow.

Our AI-powered technology has the capability of informing health decisions beyond sleep medicine, from monitoring patient health in the ICU or through wearables, to detecting and capturing seizure data, to providing earlier detection of heart disease, diabetes, stroke, and Alzheimer’s.

• Author, edit, and manage user documentation based on features in releases and requests for customer-facing documentation including:
  User manuals, reference guides, instructions for use (IFUs), and release notes; customer application notes/technical tips; and 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.
• Review internal project documentation and participate 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 workflows.

• 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.
• Recommend formats responsive to technical and customer 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,…