Medical Device Engineer

Job Summary

Seeking a Medical Device Development Engineer (Remediation) for a large remote contract project, the candidate will manage post-market activities of existing Design History Files for Medical Devices, authoring and reviewing documentation, utilizing Vault Systems, and conducting design reviews with cross-functional teams.

Key responsibilities

• Author and review existing Design History Files, identifying gaps in necessary documentation
• Utilize Vault Systems to manage document workflow and generate or update risk documentation
• Coordinate and conduct design reviews with cross-functional teams to ensure compliance and quality standards

Required qualifications

• B.S. degree in Biomedical, Mechanical, or Materials Engineering from an ABET accredited school or equivalent
• 1-4 years of medical device experience, with familiarity in Vault Systems preferred
• Strong background in DHF documentation authoring and executing for Medical Devices
• Knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T)
• Ability to work effectively within a team and give clear oral presentations