Note: The job is a remote job and is open to candidates in USA. Avania Clinical is the world's only global CRO exclusively focused on medical technology, serving 90% of the top 50 MedTech companies. The Consultant – Software & Technical Documentation will develop technical deliverables for clients, focusing on technical writing and software documentation, while collaborating with client engineering teams to ensure accurate documentation.

Responsibilities

• Perform project work with strategic input and minimal oversight, applying technical depth in software documentation and DHF deliverables
• Review and interpret client software designs, architectures, and codebases to produce accurate technical documentation aligned with applicable standards (e.g., IEC 62304, ISO 14971)
• Develop and maintain Design History File (DHF) documentation including software requirements specifications, software architecture descriptions, unit/integration/system test documentation, traceability matrices, and risk management file inputs
• Collaborate directly with client software engineering and firmware teams to gather technical information and validate documentation accuracy
• Manage specific project workstreams and interact directly with clients to ensure work is completed on budget and to client expectations
• Lead specific client interactions with oversight from senior team members
• Build rapport with clients by developing high quality deliverables, consistently meeting project deadlines, and ensuring precise and timely communication
• Prepare materials and reports for client presentation, ensuring alignment with client objectives
• Attend client meetings and provide technical documentation support where necessary
• Support new opportunity development by proofreading or providing initial drafts of Statements of Work or Work Orders, as requested

Skills

• Coding background is essential. You don't need to be writing production code in this role, but you need to have done it — enough to read and understand software architecture diagrams, review code at a structural level, and hold a technically credible conversation with a firmware or software engineering team
• Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a related technical discipline. A biomedical engineering background is particularly well-suited to this role given the intersection of engineering fundamentals and medical device context
• Familiarity with medical device industry context — you've heard of 510(k), DHF, IEC 62304, and ISO 14971, even if you haven't authored submissions or built a QMS from scratch. An understanding of why these standards exist and what they govern is what matters
• Experience producing or contributing to technical documentation: software requirements, design specifications, test protocols, traceability matrices, or similar engineering artifacts
• Proficient in Microsoft Office (Word, Excel, PowerPoint)
• Fluent in English, spoken and written, with strong technical writing skills
• Ability to travel domestically and internationally as required

Benefits

• Annual performance related bonus
• Benefits

Company Overview

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