Senior Medical Device Design Engineer

RXinsider LTD.; Brecksville (OH); On-site; USD 85,000 - 130,000; Full time

Benefits offered by this job

On-site gym

Annual employee picnic

Tuition reimbursement

401k match

Paid holidays

Job summary

AMT, near Cleveland, Ohio, seeks a design engineer to lead the development of enteral feeding and surgical devices from concept to finished design. You will manage projects, perform risk analyses, coordinate with cross-functional teams and oversee prototyping, testing, and sourcing.

The role requires 5+ years design experience in medical devices, proficiency with SolidWorks, and familiarity with FDA submissions and injection molding processes.

Qualifications

• Requires a minimum of a 4 year bachelor’s degree.
• 5+ years of relevant design and/or product development experience.
• Creative thinker with practical execution.
• Excellent communication with medical personnel.
• Advanced experience using SolidWorks or similar 3D modeling software.
• Medical device development and FDA submission experience is a plus.
• Injection molding familiarity is a plus.

Responsibilities

• Lead new product design and major improvements for current products.
• Oversee overall project management and timeline updates.
• Coordinate with engineering and other departments to complete tasks.
• Deliver extensive project status presentations.
• Conduct risk analyses and define user needs and specifications.
• Oversee design validation and clinical evaluation activities.
• Prototype and test products; source components and quotes.
• Create BOMs and assist manufacturing procedure development.
• Transfer design to manufacturing and support ongoing production.

Skills

Creative thinker

Excellent communication

Project management

FDA submissions experience

Injection molding experience

Education

Bachelor’s degree

Tools

SolidWorks

3D Printing

Mold Flow Analysis

FEA

Job description

AMT, near Cleveland, Ohio, seeks a design engineer to lead the development of enteral feeding and surgical devices from concept to finished design. You will manage projects, perform risk analyses, coordinate with cross-functional teams and oversee prototyping, testing, and sourcing.

The role requires 5+ years design experience in medical devices, proficiency with SolidWorks, and familiarity with FDA submissions and injection molding processes.