Technical Documentation Expert

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 Responsibilities

Engineering Documentation

• Develop technical documents for all work done by the R&D team, including technical specifications and test reports.
• Create and maintain clear technical documentation for System architecture and interfaces, Design assumptions and constraints, Testing procedures and results, Manufacturing and post-processing guidelines.
• Ensure documentation reflects what is actually built and tested, not just intent.

Structure & Standards

• Support compliance with ISO 13485 and other applicable prosthetic device standards.
• Define lightweight documentation standards that engineering teams can realistically follow.
• Establish naming conventions, templates, and versioning practices.
• Improve consistency across documents created by different teams.

Cross-Team Knowledge Capture

• Review test cases and 3D CAD designs and ensure they meet necessary standards.
• Work with engineers, CAD designers, and testers to extract critical technical information.
• Translate complex engineering discussions into structured, accessible records.
• Ensure integration decisions and trade-offs are recorded and traceable.

Change Tracking & Traceability

• Apply and maintain design control protocols in line with ISO, QMSR, and FDA requirements.
• Link documentation to design iterations, test results, and integration outcomes.
• Help maintain traceability between requirements, designs, tests, and revisions.
• Reduce ambiguity during handoffs between teams.

Support External Collaboration

• Prepare documentation that can be shared with external partners (e.g., print farms, collaborators) without loss of clarity.
• Ensure externally facing documents are accurate, current, and professional.

Required Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
• 7–10+ 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.
• Strong ability to understand mechanical and manufacturing concepts.
• Experience documenting complex systems, not just single components.
• Exceptional organizational and clarity skills.
• Comfortable working with engineers and asking precise follow-up questions.
• Experience working in distributed or remote teams.

Strongly Preferred (Not Required)

• Experience with prosthetic devices.
• Experience with 3D print logs.
• Comfortable using Slack and Google Workspace.
• Experience documenting regulated or safety-critical systems.
• Familiarity with version control, configuration management, or QA documentation.
• Retired or semi-retired professionals welcome.