Technical Writer; Medical Device

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-orientated 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.

Here is a little about what we are doing in the world of sleep medicine...

Enso Sleep - FDA-Cleared PSG and HSAT Scoring and Study Management

EnsoHST - FDA-Cleared, AI-Powered Sleep Diagnosis Using Pulse Oximeters

Here is a link to learn a little about our Celeste app!

The Technical Writer is responsible for creating, maintaining, and managine clear, accurate, and compliant documentation across the product lifecycle. This role supports user-documentation and translations, it may include assisting with customer-facing technical materials (such as white papers), and potentially assisting in writing regulatory submissions and quality management system processes.

Documentation Development & Maintenance

• 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.

Regulatory & Quality Support

As skill and bandwidth allow, may also participate in the following:

• 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.

Cross-Functional Collaboration

• 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).

Process Improvement

• Help standardize documentation templates, style guides, and best practices.

Education and/or Experience

• 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

Technical Skills and Competencies

• 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, Bit Bucket)
• Familiar with browser-based help systems
• Knowledge of user documentation formats

The benefits package includes, but is not limited to, the following:

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  case you didn't know, Madison has consistently been ranked as one of the top places to live in the US (, , )!

Health, dental, and…