Mechanical Design Engineer

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

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfill its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

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.

Major 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

Requirements

Skills & Experience

• Proficient in CAD design (SolidWorks preferred)
• Understanding of mechanical design principles, materials, and manufacturing processes
• Familiarity with engineering analysis and testing methods
• Experience working within regulated industries is desirable, preferably medical devices
• Good problem-solving and communication skills
• Ability to work effectively within cross-functional engineering teams

Qualifications

• 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
• Ability to travel up to 10% as required

A job description does not imply that the duties stated are the only ones to be performed by the job holder. Job holder will be required to follow any other job-related instruction as reasonably requested by their line manager or their designate.

Benefits

• We offer competitive compensation and comprehensive benefits available from day one, including health, dental, vision, disability coverage, and flexible spending accounts.
• Additionally, we offer a 401(k)-retirement plan with company matching after 90 days, paid time off, holidays, and additional leave benefits, as well as employee discounts and access to our onsite wellness facility.
• OrganOx supports work-life balance and provides opportunities for ongoing professional development.