Mechanical Design Engineer - Medical Devices (Hybrid, NJ)

OrganOx; Madison (NJ); Hybrid; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Disability coverage

401(k) with company match

Paid time off

Holidays

Job summary

OrganOx is seeking a Mechanical Design Engineer in New Jersey to design components for advanced organ perfusion devices. Hybrid work arrangement enables collaboration with engineering, quality, and regulatory teams.

The role requires a mechanical engineering degree with 2–4 years of design experience; familiarity with ISO 13485 and experience in a regulated medical device environment are desirable.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 2–4 years of mechanical design experience.
• Experience with development and testing activities in a regulated environment (medical devices desirable).
• Willingness to travel up to 10% as required.

Responsibilities

• Design mechanical components and assemblies for medical devices using CAD tools.
• Support analysis and testing activities for design verification and validation.
• Collaborate with manufacturing and suppliers to ensure manufacturability.
• Support prototype builds, testing, and engineering investigations.
• Prepare engineering documentation per ISO 13485 and applicable standards.
• Participate in risk management and design reviews.
• Work with electrical, software, quality, and manufacturing teams throughout product development.
• Adhere to OrganOx Code of Conduct and policies.

Skills

CAD

SolidWorks

Mechanical design

Regulated industry experience

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

OrganOx is seeking a Mechanical Design Engineer in New Jersey to design components for advanced organ perfusion devices. Hybrid work arrangement enables collaboration with engineering, quality, and regulatory teams.

The role requires a mechanical engineering degree with 2–4 years of design experience; familiarity with ISO 13485 and experience in a regulated medical device environment are desirable.