Medical Device Engineer

Job Summary

Seeking a Medical Device Development Engineer (Remediation) for a large remote 11-month project, the candidate will manage post-market activities of existing Design History Files for Medical Devices, requiring strong organizational skills and self-motivation.

Key responsibilities

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

Required qualifications

• B.S. degree in Biomedical, Mechanical, or Materials Engineering from an ABET accredited school or equivalent
• 1-4 years of experience in medical device development, with familiarity in Vault Systems preferred
• Strong background in DHF documentation authoring and execution for Medical Devices
• Knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T)
• Ability to work effectively in teams and present technical information clearly