Sustaining Engineer

Sustaining Engineer

Requirements

• Bachelor’s degree in an engineering discipline
• Experience in medical devices and/or orthopedics preferred
• Must be experienced in MS Word, Excel and Project
• Prior experience with 3D CAD packages (SolidWorks preferred)

Responsibilities

• Supports various sustaining engineering projects including line extensions and supplier/internal manufacturing transfer projects
• Supports new product development projects from proposal to final design/release
• Creates product designs and documentation used to substantiate those devices (i.e. risk assessments, verification/validation activities, design review documentation, etc.)
• Develops detailed engineering drawings using 3-D Modeling to document designs and design changes (SolidWorks)
• Confers with cross-functional team to identify tasks and requirements (Product Development, Manufacturing Engineers, Quality Engineers, Marketing, Purchasing and Regulatory Affairs)
• Maintains all documentation necessary for a Design History File (DHF), including Design Input Documents, Design Validation Plans/Reports, Test Protocols/Reports, and Design Input/Output Matrix
• Provides technical support and review for Non-Conforming Material Reports and product complaint investigations
• Provides technical support and review for Corrective and Preventative Actions and Health Hazard Evaluations.

Preferred Qualifications

• Prior experience assisting in the 510(k) application process by providing official test batch and qualification information for FDA review
• Previous experience in a regulated environment, Medical Device, Aeronautics, Automotive or other highly regulated industry required
• Working knowledge and requirements of ISO 13485 and 21CFR820
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Prepare product reports by collecting, analyzing, and summarizing information and trends.