Note: The job is a remote job and is open to candidates in USA. Avania is a global CRO focused on medical technology, serving top MedTech companies. They are seeking a Consultant for their Advisory Services division to work closely with client engineering teams on software and technical documentation, ensuring compliance and accuracy in design history files.
Responsibilities
- 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
- 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
Skills
- Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a related technical discipline
- Experience working in or around regulated software environments with knowledge of 510(k), DHF, IEC 62304, and ISO 14971
- Ability to discuss a specific piece of software you've built or maintained, explaining design decisions
- Ability to review regulatory documentation and identify areas for improvement or clarification
- 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
Benefits
- Annual performance related bonus
- Benefits
Company Overview
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