Medical Device Quality Engineer

Job Summary

A company is looking for Medical Device Development and Quality Engineers for a remote project.

Key Responsibilities

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

Required Qualifications

• B.S. degree in Biomedical, Mechanical, or Materials engineering from an ABET accredited school or equivalent
• Three to five years of medical device experience
• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
• Strong background in DHF documentation authoring for Medical Devices
• Ability to work effectively within a team to meet project deadlines