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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