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# Consultant - Advisory Services - Software & Technical Documentation

- **Company:** Avania, LLC
- **Location:** United States (Remote available)
- **Salary:** $80,000.0 - $120,000.0
- **Contract:** Permanent contract
- **Skills:** Artificial Intelligence, Embedded Software, Microsoft Office, Software Engineering, Information Technology
- **Published:** July 17, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=82601a8096521993

## About the Role

Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a related technical discipline. Biomedical engineering is particularly well-suited given the intersection of engineering fundamentals and medical device context.

You've worked in or around regulated software environments enough to know what 510(k), DHF, IEC 62304, and ISO 14971 actually mean in real-world practice.

You should be able to talk through a specific piece of software you've built or maintained, in enough depth to explain a design decision you made and why. You should be able to look at a piece of regulatory documentation and spot where FDA would need it to be improved or clarified. We'll ask you to do both.

Proficient in Microsoft Office. Fluent in English, spoken and written, with strong technical writing skills.

Ability to report to Toronto or Boston in person as required for training, client work, and/or team events.

## Description

This is a hands-on role for someone who's actually built software, not just worked adjacent to it. You'll sit across from a client's engineering team, look at their real architecture and codebase, and be able to tell the difference between what the code actually does and what the client's documentation claims it does. That gap is usually where the real Design History File work happens.

You'll be doing this across a mix of software-only SaMD, embedded firmware in Class II/III devices, and AI/ML products navigating predetermined change control, so comfort moving between very different codebases matters more than deep expertise in any single language.

General Responsibilities

This role goes beyond summarizing what you're told in a document or filling in a template. You will sit with client engineering teams and work through their codebase and architecture at a level of detail that lets you catch inconsistencies between what's documented and what's implemented. You will turn that review into device descriptions, DHF deliverables, requirements specs, architecture descriptions, and traceability matrices built to survive an FDA reviewer's scrutiny. You will contribute risk management file inputs by understanding actual software failure modes, not just citing the standard that requires them.


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