Product Engineer

OrganOx Limited; Alabama; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Disability coverage

401(k)

Paid time off

Holidays

Wellness facility

Employee discounts

Professional development

Job summary

OrganOx Limited seeks a Product Engineer to join the Product Engineering team. You will support design changes, verify features, and drive improvements for the current product range.

Collaboration with operations, quality, and service teams will be essential to resolve obsolescence, manufacturing issues, and field concerns. The role requires a background in engineering or sciences, experience in electro-mechanical devices, and strong documentation skills to meet ISO13485 standards.

Qualifications

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related discipline.
• 5–7 years of experience in a similar role.
• Experience with regulated medical device environments (ISO 13485) and quality systems.
• Experience in debugging, design changes and documentation.

Responsibilities

• Contributing to design changes to support product, production and quality improvements.
• Investigating device performance issues, determining root cause with cross-functional teams, and recommending corrective actions.
• Interpreting and understanding the product’s intended use, clinical procedures, customer needs and design inputs.
• Creating and refining engineering documentation, such as the Design History File and the Device Master Record.
• Following R&D procedures, such as failure analysis, design controls and risk management, per the Quality Management System.
• Assisting prototyping efforts and bench testing.
• Prepare reports and conclusions for presentation.
• Ensuring compliance with ISO 13485 and local procedures.

Skills

Product engineering

Medical devices

Electro-mechanical design

Test plan design

Root cause analysis

Technical reporting

Cross-functional collaboration

Communication skills

Education

Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, or related

Job description

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

OrganOx is in the process of 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 in the following areas;

• Support the implementation and verification of design changes on the existing product range, to introduce new features and functionality and drive continuous improvement.
• Work closely with the operations team in resolving component obsolescence, manufacturing issues, or complaints on the existing OrganOx product.This will require close partnership with field-based Customer service, Operations, and Quality teams.
• Supporting the creation of assembly and test instructions required by the Operations team and suppliers, to ensure the transfer of designs to production are delivered in accordance with design change and operational SOPs.
• Working closely with Product Development and Innovations teams throughout development projects with a focus on supporting design reviews and design transfer activities.

The ideal candidate will have a background in relevant science or engineering discipline.

The successful candidate will work within a small, multi-disciplinary team of engineers, including electronics, mechanical and software development.

The post holder will support activities relating to design changes and develop test strategies to ensure all changes are effectively implemented.

The candidate requires excellent written and verbal communication skills to document their activities in line with the ISO13485 Quality Management System, planning and reporting on their work to a standard suitable for review by regulatory authorities.

Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed.

Major Responsibilities

The Product Engineer will be responsible for:

• Contributing to design changes to support product, production and quality improvements. This includes conducting problem-solving efforts and root cause analysis.
• Investigating device performance issues, determining, and reporting the root cause (in collaboration with the 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.
• Prepare 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

The Product Engineer will have:

• 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

The Product Engineer will have:

Essential:

• 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.

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

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.