Medical Device Quality & Risk Design Specialist

TechDigital Group; Bothell (WA); On-site; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a talented Mechanical Engineer with a robust background in medical device product design. In this role, you will leverage your expertise to innovate and develop mechanical components while ensuring compliance with FDA standards. You'll be responsible for executing design methodologies, conducting rigorous testing, and collaborating with cross-functional teams to deliver high-quality products. This dynamic position offers the opportunity to make a significant impact in the medical field, where your contributions will enhance patient safety and product efficacy. Join a forward-thinking organization that values creativity and excellence in engineering.

Qualifications

• 4+ years of experience in medical domain product design.
• Strong knowledge of FDA standards and medical device usability.

Responsibilities

• Define product and design options using VOC methodologies.
• Create and manage component approval documents and test protocols.
• Optimize manufacturing processes using DFMA principles.

Skills

Product Design

Mechanical Engineering

Research and Development

Statistical Analysis

Project Management

Education

Bachelor in Mechanical Engineering

Tools

Creo

Windchill

DFMEA

PFMEA

DOE

GD&T

Job description

An established industry player is seeking a talented Mechanical Engineer with a robust background in medical device product design. In this role, you will leverage your expertise to innovate and develop mechanical components while ensuring compliance with FDA standards. You'll be responsible for executing design methodologies, conducting rigorous testing, and collaborating with cross-functional teams to deliver high-quality products. This dynamic position offers the opportunity to make a significant impact in the medical field, where your contributions will enhance patient safety and product efficacy. Join a forward-thinking organization that values creativity and excellence in engineering.