Product Development Engineer – Medical Devices

Job Summary

We are looking for an experienced

Product Development Engineer

with a strong background in

medical device product development, mechanical design, and sustaining engineering

.

Required Qualifications

• Bachelor’s degree in

Mechanical Engineering

or related field

• 10\+ years of experience

in medical device product development

• Strong hands-on experience in

mechanical design and product development

• Proficiency in

SolidWorks

– 3D modeling, sheet metal, 2D drawings, and assemblies

• Strong understanding of

DFM/DFA, GD\&T, material selection, and manufacturing processes

• Experience with

New Product Development (NPD)

processes

• Experience with

Engineering Change Management

– ECN, ECR, DCO

• Hands-on experience with

PLM/EPDM

for component lifecycle management

• Experience developing and executing

test plans, verification \& validation activities

• Experience with

electro-mechanical products and laboratory instruments

• Knowledge of

medical device compliance requirements and standards