Mechanical Design Engineer

OrganOx•Madison, NJ

28d•Hybrid

About The Position

The Mechanical Design Engineer will support the design and development of mechanical components and assemblies for OrganOx products. The role will involve working closely with cross-functional teams to ensure designs meet performance, manufacturability, safety, and regulatory requirements. This is a hybrid position based in New Jersey to ensure close collaboration with engineering, quality, and regulatory teams.

Requirements

Proficient in CAD design (SolidWorks preferred)
Understanding of mechanical design principles, materials, and manufacturing processes
Familiarity with engineering analysis and testing methods
Good problem-solving and communication skills
Ability to work effectively within cross-functional engineering teams
Bachelor’s degree or higher in Mechanical Engineering or related field
Minimum 2–4 years of mechanical design experience
Experience supporting products through development and testing activities

Nice To Haves

Experience working within regulated industries is desirable, preferably medical devices

Responsibilities

Designing mechanical components and assemblies for medical devices using CAD tools
Supporting engineering analysis and testing activities to aid design verification and validation
Collaborating with manufacturing and suppliers to ensure designs are practical and manufacturable
Supporting prototype builds, testing, and engineering investigations
Preparing engineering documentation in accordance with ISO 13485 and other applicable standards
Participating in risk management and design review activities
Working collaboratively with electrical, software, quality, and manufacturing teams throughout the product development lifecycle
Adhering to the letter and spirit of OrganOx’s Code of Conduct and all other company policies