Our engineering team is a booster rocket for accelerating medical device design; we help clients launch products with certainty.

We fold into client development teams, working alongside as design partners. Our uniquely-integrated approach means lower-risk development and more transparency. 

Our team’s portfolio includes FDA Class II, III and PMA devices. We plan, specify, architect, design, prototype, verify, validate and transfer devices to production. Our focus is on electronic, mechanical and embedded software medical devices. 

Because of our medical device focus, we have an ISO:13485 / 21CFR820 - compliant quality system.

Life Sciences

Health Care

Medical Devices

Engenious Design

Chris Justice

Holly Justice

Melissa Nickel

Brian Hatesohl

The Engineering Team at Engenious Design specializes in the comprehensive development of medical devices, working closely with clients as integrated design partners. With expertise spanning mechanical, electrical, and software engineering, the team is responsible for all stages of product development including planning, prototyping, testing, and ensuring compliance with FDA regulations. Their commitment to quality and collaboration helps accelerate the launch of innovative medical technologies with reduced risk and enhanced transparency.

Engineering Team

Project Management and Coordination

Engineering and Product Development

Engineering Team

About

Team members

Other teams at Engenious Design

Project Management and Coordination

Engineering and Product Development