About the Role We are seeking an experienced Medical Device Design Documentation Engineer to support post-market activities for existing Design History Files (DHFs) within a regulated medical device environment. Reporting to a Project Leader or Manager, you will contribute to the maintenance, update, and execution of DHF documentation while collaborating closely with Regulatory, Quality, and Engineering teams. This role requires strong technical writing skills, attention to detail, and the ability to work effectively in cross-functional teams to ensure compliance with quality and regulatory requirements.

Main Responsibilities Support post-market activities related to existing Design History Files (DHF) for medical devices in accordance with regulatory and quality requirements. Author, update, review, and maintain DHF documentation, technical files, and associated engineering records. Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Engineering, to ensure timely completion of critical project deliverables. Ensure documentation complies with applicable drafting standards, geometric dimensioning and tolerancing (GD&T) requirements, and internal procedures. Contribute to the development and implementation of process methods that meet performance, quality, and compliance objectives. Prepare technical reports, presentations, and documentation while communicating project status, risks, and recommendations clearly to stakeholders.

Qualifications Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Materials Engineering, or an equivalent engineering discipline from an accredited institution. 5–7 years of experience in medical device engineering, design documentation, or post-market support within a regulated environment. Strong expertise in DHF documentation authoring, execution, and maintenance for medical devices. Familiarity with Vault systems (preferred), document management systems, and engineering documentation workflows. Knowledge of drafting standards and GD&T, with the ability to review and interpret engineering drawings and technical documentation. Excellent technical writing, communication, teamwork, organizational, and presentation skills, with the ability to work independently as a self-starter in a fast-paced environment.