Technical Documentation Expert - Volunteer

Résumé du poste

The Technical Documentation Expert is responsible for capturing and structuring engineering knowledge to ensure it is accurate and usable. This includes creating and maintaining technical documentation and supporting compliance with relevant regulatory requirements.

Détails du poste

Universal Limbs - Department: Research & Development Role Overview:The Technical Documentation Expert is responsible for ensuring that engineering knowledge is captured, structured, accurate, and usable across the organization. We operate multiple engineering teams working in parallel, with external partners and rotating volunteers. This role exists to prevent the loss of institutional knowledge and to ensure that decisions, interfaces, tests, and outcomes are documented clearly enough to be reused, audited, and trusted. This is not a copy-editing role. It is a technical clarity role.This role also carries responsibility for the team's design control process and for supporting compliance with ISO 13485, QMSR, applicable FDA standards, and other regulatory requirements relevant to prosthetic and medical device development. Key Responsibility: Engineering Documentation: Create and maintain clear technical documentation for: Bill of Materials CAD package Manufacturing drawings Print settings Assembly instructions Testing procedure Testing report Technical specifications University handoff package Structure and Standard: Establish naming conventions, templates, and versioning practices. Improve consistency across documents created by different teams. Support compliance with ISO 13485 and maintain design control protocols in line with ISO, QMSR, and FDA requirements. Review test cases and 3D CAD designs and ensure they meet necessary standards. Requirement Qualifications: Bachelor's degree in Engineering, Biomedical Engineering, or a related field. 3+ years experience in technical documentation, engineering documentation, or technical writing within engineering environments. Experience in medical device documentation or quality systems. Working knowledge of ISO 13485 and ISO 14971. Exceptional organizational and clarity skills (strong technical writing and organizational skills). Comfortable working with engineers and asking precise follow-up questions. Ideal: Experience with prosthetic devices & 3D prints. Comfortable using Slack and Google Workspace.

Ce que vous ferez

The Technical Documentation Expert is responsible for capturing and structuring engineering knowledge to ensure it is accurate and usable. This includes creating and maintaining technical documentation and supporting compliance with relevant regulatory requirements.

Exigences

Candidates should have a bachelor's degree in Engineering or a related field and at least 3 years of experience in technical documentation within engineering environments. Familiarity with ISO standards and exceptional organizational skills are also required.

Compétences indiquées

• Control · Souhaitée
• Technical Documentation · Souhaitée
• Technical · Souhaitée
• Sens de l’organisation · Souhaitée
• materials · Souhaitée
• Souci du détail · Souhaitée
• Teams · Souhaitée
• responsibility · Souhaitée
• Compliance · Souhaitée
• Process · Souhaitée
• Documentation · Souhaitée
• Development · Souhaitée

Autres compétences pertinentes

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Technical Documentation
• Engineering Documentation
• Technical Writing
• ISO 13485
• Quality Systems
• Organizational Skills
• 3D CAD
• Prosthetic Devices
• Medical Device Development
• Bill of Materials
• Manufacturing Drawings
• Testing Procedures
• Versioning Practices
• Assembly Instructions
• Testing Reports
• Technical Specifications

Domaines d’emploi

• Healthcare
• Engineering
• Science & Research
• Manufacturing
• Consulting