Development Engineer II, Base Business

Enovis•Austin, TX

2d•Hybrid

About The Position

As a key member of the Enabling Technologies, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes. The Product Development Engineer will design, test, and participate in development activities for company products. This includes but is not limited to interfacing with physicians and other customers to determine needs/requirements; creating prototypes, testing, and documenting test results; scheduling, coordinating, and managing multiple projects; and communicating with vendors to ensure product quality. The Product Development Engineer will be responsible for products including mechanical surgical instrumentation, electronic hardware, and software used by electronic hardware.

Requirements

Bachelor's degree in an engineering discipline
2+ years of professional experience (1 year with a Masters degree)
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
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
Familiarity with software development processes
Working knowledge and requirements of ISO 13485 and 21CFR820.

Responsibilities

Participate in product development including concept, generation, decision matrices, prototype, manufacture, and associated metrics
Provide detailed design and development output for the development projects assigned; this includes unrelenting attention to minimizing project delays and resource overages
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.
Assist in the 510(k) application process by providing official information for FDA review