Technical Writer (Medical Device)

EnsoData • Madison, WI

6h • $85,000 - $95,000 • Hybrid

About The Position

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. About EnsoData EnsoData 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, EnsoSleep, 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... EnsoSleep - 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! Key Responsibilities 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.

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
• 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

Nice To Haves

• 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

Responsibilities

• 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.

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!)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees