Medical Device Engineer

Job Summary

Seeking a Medical Device Development Engineer (Remediation) for a large remote 10-month contract project, responsible for authoring and reviewing Design History Files, managing document workflows using Vault Systems, and generating risk documentation for medical devices.

Key responsibilities

• Author and review existing Design History Files, identifying gaps in necessary documents
• Utilize Vault Systems to manage document workflow and coordinate design reviews with cross-functional teams
• Generate and analyze risk documentation, including DFMEA and design verification protocols

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 or PLM like Windchill
• Strong background in DHF documentation authoring for medical devices
• Knowledge of drafting standards and geometric dimensioning and tolerancing (GD&T)
• Ability to work effectively within a team and present technical information clearly