Sustaining Engineer

Enovis•Houston, TX

14h•Onsite

About The Position

As a key member of the Foot & Ankle Research & Development team, the Sustaining Engineer will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The Sustaining Engineer will primarily be responsible for providing technical support to RA/QA/MFG for NCMR, CAPA/HHE, validations and complaint investigations. Additionally, the sustaining engineer will own sustaining/product improvement projects and provide support to upper-level engineers in all aspects of new product development projects from proposal to final design/release, including design transfer support (internal and supplier transfer). The engineer will work with a cross-functional product team consisting of upper-level product development engineers, marketing product managers, manufacturing engineers, regulatory and QA engineers in the design, development, and design transfer of surgical instruments and implants.

Requirements

Bachelor's degree in an engineering discipline
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Prepare product reports by collecting, analyzing, and summarizing information and trends.
Assist in the 510(k) application process by providing official test batch and qualification information for FDA review
Must be experienced in MS Word, Excel and Project.
Experience with 3D CAD packages (SolidWorks preferred)

Nice To Haves

Experience in medical devices and/or orthopedics 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.