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.

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.

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.
• 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.

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
• 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

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, BitBucket)
• 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 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!)

Interview Process

1. Submit a resume online and our hiring team will choose those that seem like the best candidates.
2. We look forward to meeting you face-to-face! A few candidates will be chosen for a video call to get to know each other, discuss your experience, and explain the position in more detail.
3. Expect an opportunity to show your skills. A few candidates may be asked to submit samples of previously published work.
4. The final candidates will have a chance to meet a few people from the team.
5. Offer!

Let’s talk

EnsoData seeks to recruit, hire, and retain the most talented people from a diverse candidate pool. Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women and other marginalized folks tend to only apply when they check every box. If you think you’re a great fit, but don't necessarily check every box on the job description, please still get in touch.

To learn more about our ongoing commitment to diversity, check here.

Note: this role is based in the continental United States and currently EnsoData is unable to support sponsorships so candidates must be legally eligible to work and reside in the United States now and in the future.

Equal Employment Opportunity
EnsoData is proud to be an Equal Employment Opportunity employer. We do not discriminate against, nor do we tolerate unlawful harassment against, team members or any other covered persons on any basis of race, color, protective hairstyles, national, social, or ethnic origin, gender, pregnancy, childbirth, gender orientation, identity or expression, sexual, relationship, or romantic orientation, marital, civil union or domestic partnership status, family or parental status, age, protected veteran status, arrest record, expunged or sealed convictions, criminal history, source of income, credit history, housing status, physical, mental, or sensory disability, medical condition, genetic information, religion, or any other status protected by the laws or regulations in the locations where we operate.

We value, celebrate, and support diversity, inclusion, and our differences. We are committed to providing a safe work environment and a company culture of mutual respect where equal employment opportunities are available to all applicants and teammates. We seek to recruit, hire, and retain the most talented people from a diverse candidate pool. We strongly encourage women, people of color, LGBTQIA+ individuals, people with disabilities, members of ethnic minorities, intersectional individuals, foreign-born residents, and veterans to apply. We have a deep conviction that diversity and inclusion among our teams, our communities, and our physical and virtual workplaces is vital to the success of EnsoData’s mission to improve healthcare access, outcomes, and affordability for patients and communities everywhere globally.

If you are a job seeker applying to EnsoData and you feel that you need to request an accommodation or alternative application, please contact Angela at [email protected].