Consultant - Advisory Services - Software & Technical Documentation

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.

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.

Avania is the only global CRO built for MedTech - integrating regulatory strategy, clinical development, and market access and reimbursement to take innovations from concept to commercialization with confidence. Avania was purpose-designed to serve medical technology innovators, combining regulatory, clinical, engineering, and market access expertise to guide products across the full lifecycle

Join our team of subject matter experts and contribute to the development of life-changing medical devices that improve patients’ lives worldwide., Avania Clinical is the world’s only global CRO exclusively focused on medical technology, serving 90% of the top 50 MedTech companies across eight offices on three continents.

Our Advisory Services division provides premium consulting across regulatory strategy, quality and compliance, R&D engineering, and AI/SaMD guidance. We work with everyone from Series A startups bringing their first device to market to Fortune 500 MedTech leaders launching next-generation AI-enabled platforms.