Medical Device Engineer

Job Summary

A company is looking for a Medical Device Development Engineer (Remediation).

Key Responsibilities

• Author and review existing Design History Files, identifying gaps in documentation
• Utilize Vault Systems to manage document workflow and generate risk documentation
• Coordinate design reviews with cross-functional teams and conduct design verification and validation testing

Required Qualifications

• B.S. degree in Biomedical, Mechanical, or Materials Engineering from an ABET accredited school or equivalent
• 1 to 4 years of experience in medical device development
• Familiarity with Vault Systems and drafting standards including GD&T
• Strong background in DHF documentation for medical devices
• Ability to work effectively within a team and manage project tasks