ABOUT ORGANOX:

OrganOx is an innovative, fast-paced, global medical device company with a mission to save lives by making every donated organ count. We are a commercial stage organ technology company, spun out of the University of Oxford in 2008, committed to improving transplantation outcomes throughout the world. The company's first product, the OrganOx metra® normothermic machine perfusion (NMP) system for liver transplantation, has been used to support more than 5,000 liver transplant operations globally.

Position Summary

As part of a small multi-disciplinary Product Engineering team, the Mechanical Product Engineer will support design activities in the following areas:

• Identifying, implementing, and verifying design changes relating to product enhancements, component obsolescence and complaints resolutions on the existing OrganOx product range
• Supporting the creation of assembly instructions and outputs required by the Operations team, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs
• Working closely with the New Product Development and Operations teams throughout development projects with a focus on supporting design reviews and design transfer activities
  
  

The incumbent will be responsible for risk management, change control, tolerance analysis, DfMA and the development of test methods and protocols.

The incumbent will create, control, and maintain detailed CAD assemblies, parts, and drawings, therefore experience in SOLIDWORKS and PDM is essential. Additionally, the incumbent will be responsible for document their activities in line with the ISO13485 Quality Management System.

The OrganOx device consists of a transportable active device and a single-use sterile, disposable set. Both systems utilise a number of components from external suppliers and the role will require collaboration with suppliers to ensure that design requirements are well specified and that designs meet specification.

This is a full time, in office role located at OrganOx's US headquarters in Madison, NJ.

Major Responsibilities

Responsible for the aspects of mechanical design on the OrganOx product and sub-systems.

• Ensure all design changes are carried out in accordance with design control and design change processes, whilst maintaining compliance with applicable standards
• Design, source and verify new components and assemblies
• Detail, release and maintain 2D and 3D mechanical parts, assemblies, and drawings in SolidWorks
• Perform device Risk Analysis/ FMEA activities
• Prototyping and assembly of parts to facilitate the test and validation process
• Develop test methodologies for verification/validation activities
• Supporting root cause analysis and implement changes for complaints resolution Ensuring designs are robust, well-evaluated and capable of withstanding the lifetime requirements of transportable electromechanical devices
• Collaborate with the Operations team to ensure assembly, and service requirements are considered throughout the design change process
• Input to design for manufacture and assembly reviews on new products
• Ensuring that CAD, drawings, and design outputs are effectively transferred to production for new product introductions
  
  
  

Requirements

Qualifications

• Bachelor's Degree or equivalent qualification/experience in mechanical engineering, or other relevant engineering discipline
• 5+ years medical device or other highly regulated industry experience; Previous experience in medical devices under ISO 13485 QMS is also advantageous
• Proficiency in CAD software & CAD Management System (Solidworks & PDM)
• Experience in risk management, change control, tolerance analysis, DFMA and the development of test methods and protocols
  
  

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

The Pay Range for this position is $120,000 - $130,000 annually, with a 10% target annual bonus and benefits.

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.