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Product Engineer

OrganOx

Madison, NJOnsitePosted 21 days ago
Full TimeSenior LevelManufacturing & CMCMedical Device
Original posting ↗

Summary

OrganOx is expanding its engineering capability and is seeking an enthusiastic Product Engineer to join the Product Engineering team. As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range.

Job description

Position Summary

OrganOx is expanding its engineering capability and is seeking an enthusiastic Product Engineer to join the Product Engineering team. As part of a small multi-disciplinary Product Engineering team, the successful candidate will have responsibility for activities focused on the existing product range.

Major Responsibilities

  • Contributing to design changes to support product, production and quality improvements, including problem-solving efforts and root cause analysis.
  • Investigating device performance issues, determining and reporting the root cause in collaboration with quality, service and operations departments, and recommending corrective actions.
  • Interpreting and understanding the product's intended use, clinical procedures, customer needs and design inputs.
  • Creating and/or refining engineering documentation, such as the Design History File and the Device Master Record.
  • Following, learning, and contributing to R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System.
  • Assisting prototyping efforts and bench testing.
  • Preparing reports and conclusions for presentation.
  • Ensuring compliance with design and development procedures and ensuring all associated documentation is complete in accordance with ISO 13485 and local procedures.

Skills and Experience

  • Demonstrable experience within Product Engineering/Product Development, preferably within medical devices or another highly regulated industry.
  • Experience with electro-mechanical devices, with understanding of how to drive, interface with and troubleshoot devices.
  • Ability to design, implement and carry out experimental test plans for electro-mechanical, fluid components, sub-systems, and complete safety-critical systems.
  • Ability to produce technical reports to a high standard both in terms of technical content, presentation, and written English.
  • Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team.
  • Ability to work effectively with outside suppliers and manufacturers.
  • Ability to work across and manage a range of projects or tasks simultaneously.

Qualifications

  • Bachelors degree or equivalent qualification/experience in Computer Science, Software Engineering, Biomedical Engineering, or other relevant disciplines.
  • 5-7 years of experience of working in a similar role.

Requirements

  • Bachelors degree or equivalent qualification/experience in Computer Science, Software Engineering, Biomedical Engineering, or other relevant disciplines
  • 5-7 years of experience of working in a similar role
  • Demonstrable experience within Product Engineering/Product Development, preferably within medical devices or another highly regulated industry
  • Experience with electro-mechanical devices, with understanding of how to drive, interface with and troubleshoot devices
  • Ability to design, implement and carry out experimental test plans for electro-mechanical, fluid components, sub-systems, and complete safety-critical systems
  • Ability to produce technical reports to a high standard both in terms of technical content, presentation, and written English
  • Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team
  • Ability to work effectively with outside suppliers and manufacturers
  • Ability to work across and manage a range of projects or tasks simultaneously

Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • Disability Coverage
  • Flexible Spending Accounts
  • 401(k) Matching
  • Paid Time Off
  • Holidays
  • Employee Discounts
  • Onsite Wellness Facility

Company overview

OrganOx is a pioneering medical technology company specializing in advanced organ preservation devices for transplantation. Founded in 2008 as a spin-off from the University of Oxford by Professor Peter Friend and Professor Constantin Coussios, the company developed the world's first normothermic liver perfusion device, the metra® system. This innovative technology enables normothermic machine perfusion (NMP), which preserves organs at near-body temperature by circulating oxygen and nutrient-rich perfusate, allowing for real-time monitoring of organ condition during storage and transport. The metra® system has been used in over 6,000 liver transplant procedures globally and has received regulatory approvals in the U.S., Europe, Australia, and Canada. OrganOx's technology addresses critical challenges in organ transplantation by improving organ utilization rates, enabling the use of marginal donor organs, enhancing post-transplant outcomes, and reducing the burden on healthcare professionals. In 2025, the company was acquired by Terumo Corporation for approximately $1.5 billion, marking Terumo's strategic entry into the organ transplantation sector. OrganOx continues to expand its technology platform, with investigational applications for kidney transplantation and partnerships for innovative organ support solutions.

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