Medical Device Development Engineer

Job Summary

Working remotely on a contract basis, the Medical Device Development Engineer will manage post-market activities of existing Design History Files for Medical Devices, focusing on documentation authoring, risk analysis, and cross-functional design reviews.

Key responsibilities

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

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 preferred
• Strong background in DHF documentation authoring and execution for Medical Devices
• Understanding of drafting standards and geometric dimensioning and tolerancing (GD&T)
• Proficiency in Microsoft Office Suite and technical writing skills