[Remote] Consultant - Advisory Services

Note: The job is a remote job and is open to candidates in USA. Avania is a global CRO focused exclusively on medical technology, serving top MedTech companies. The Consultant in Advisory Services will work on technical documentation and product development, collaborating with client engineering teams to create accurate, standards-compliant deliverables.ResponsibilitiesPerform project work with strategic input and minimal oversight, applying technical depth in software documentation and DHF deliverablesReview 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 inputsCollaborate directly with client software engineering and firmware teams to gather technical information and validate documentation accuracyManage specific project workstreams and interact directly with clients to ensure work is completed on budget and to client expectationsLead specific client interactions with oversight from senior team membersBuild rapport with clients by developing high quality deliverables, consistently meeting project deadlines, and ensuring precise and timely communicationPrepare materials and reports for client presentation, ensuring alignment with client objectivesAttend client meetings and provide technical documentation support where necessarySupport new opportunity development by proofreading or providing initial drafts of Statements of Work or Work Orders, as requestedSkillsCoding 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 teamDegree 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 contextFamiliarity 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 mattersExperience producing or contributing to technical documentation: software requirements, design specifications, test protocols, traceability matrices, or similar engineering artifactsProficient in Microsoft Office (Word, Excel, PowerPoint)Fluent in English, spoken and written, with strong technical writing skillsAbility to travel domestically and internationally as requiredBenefitsAnnual performance related bonusBenefitsCompany OverviewAvania is a full-service contract research organization focused on the management of clinical studies for medical devices, IVDs, biologics. It was founded in 1988, and is headquartered in Marlborough, Massachusetts, USA, with a workforce of 201-500 employees. Its website is https://www.avaniaclinical.com/.Company H1B SponsorshipAvania has a track record of offering H1B sponsorships, with 1 in 2024. Please note that this does not guarantee sponsorship for this specific role.