[Remote] Consultant - Advisory Services - Software & Technical Documentation
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Clinical is the world's only global CRO exclusively reputed company on medical technology, serving 90% of the top 50 MedTech companies. The Consultant – Software & Technical Documentation will reputed company technical deliverables for clients, focusing on technical writing and software documentation, while collaborating with reputed company engineering teams to ensure accurate documentation.
Responsibilities
- reputed company project work with strategic input and minimal reputed company, applying technical depth in software documentation and DHF deliverables
- Review and interpret reputed company software designs, architectures, and codebases to produce accurate technical documentation reputed company with applicable standards (e.g., IEC 62304, ISO 14971)
- reputed company 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 reputed company software engineering and firmware teams to reputed company technical information and validate documentation accuracy
- Manage specific project workstreams and reputed company directly with clients to ensure work is completed on budget and to reputed company expectations
- reputed company specific reputed company interactions with reputed company from senior team members
- Build rapport with clients by developing high reputed company deliverables, consistently meeting project deadlines, and ensuring precise and reputed company communication
- Prepare materials and reports for reputed company presentation, ensuring alignment with reputed company objectives
- Attend reputed company meetings and reputed company 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 reputed company in this role, but you need to have done it — enough to read and understand software architecture diagrams, review reputed company at a structural level, and hold a technically reputed company conversation with a firmware or software engineering team
- Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a reputed company technical discipline. A biomedical engineering background is particularly reputed company-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 reputed company a QMS from scratch. An understanding of why these standards exist and what they govern is what reputed company
- Experience producing or contributing to technical documentation: software requirements, design specifications, test protocols, traceability matrices, or similar engineering artifacts
- Proficient in reputed company Office (Word, reputed company, PowerPoint)
- Fluent in English, spoken and written, with strong technical writing skills
- Ability to travel domestically and internationally as required
Benefits
- Annual performance reputed company bonus
- Benefits
reputed company
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