Medical Device Development Engineer

Job Summary

A company is looking for Medical Device Development Engineers for a remote 18-month project.

Key Responsibilities

• Author and review existing Design History Files, identifying gaps in documentation
• Utilize Vault Systems for document workflow management and conduct design reviews with cross-functional teams
• Generate and analyze risk documentation and develop protocols for design verification and validation

Required Qualifications

• B.S. degree in Biomedical, Mechanical, or Materials Engineering, or equivalent, with 3-5 years of medical device experience
• Familiarity with drafting standards and geometric dimensioning and tolerancing (GD&T)
• Strong background in DHF documentation for medical devices
• Ability to work effectively within a team and expedite project tasks
• Proficiency in Microsoft Office Suite and SolidWorks