· Develop and maintain a comprehensive and audit-ready documentation package aligned with regulatory and quality system requirements.

· Ensure documentation compliance with IEC 62304, ISO 14971, IEC 60601, and ISO 13485.

· Coordinate, review, and integrate documentation from external development partners into CathRx’s internal quality system.

· Maintain Risk Management Files in accordance with ISO 14971.

· Develop and maintain System and Software Requirements Specifications to support product development and verification.

· Support regulatory submissions and audits with complete, inspection-ready documentation.

· Develop Verification & Validation Protocols in collaboration with QA and engineering teams.

· Create and maintain Traceability Matrices to ensure full coverage of requirements through testing.

· Compile and manage Design History Files (DHF) in line with regulatory expectations.

· Act as the documentation lead for the project, ensuring timely delivery of all compliance artifacts.

· Collaborate with cross-functional teams including R&D, QA/RA, Clinical, and Manufacturing to align documentation with development milestones

· Be able to read schematics and mechanical drawings.

Requirements

· Bachelor’s or master’s degree in engineering (Biomedical, Systems, Electrical, or related)

· 5+ years’ experience in medical device development

· Proven experience with electromechanical medical devices

· Strong knowledge of ISO 13485, ISO 14971, IEC 62304, and IEC 60601

· Demonstrated ability to produce high-quality technical documentation

· Excellent organizational and communication skills

· Experience with manufacture and release/rollout of software and configuration.

This position is a 1-year full time contract.