ABOUT ORGANOX:
OrganOx has been transforming organ transplantation since 2008, leveraging groundbreaking normothermic machine perfusion technology in our flagship product, the OrganOx metra ®. This technology helps preserve donor livers for up to 12 hours, in efforts to reduce organ discard rates and facilitate more successful transplants. We are an innovative, fast-paced global medical device company committed to improving transplantation outcomes. As part of our ongoing expansion in North America, we seek a motivated Field Service Engineer to join our team.
Position available in: Dallas, Texas
Position Summary
The Field Service Engineer-United States will be primarily responsible for the on-site service and repair of complex electro-mechanical medical devices designed for organ preservation placed within United States region. Reporting to the Senior. Field Service Engineer, the postholder will be responsible for providing technical support for OrganOx metra retained units placed in United States to ensure that product reliability, quality and availability are maintained. The Field Service Engineer – United States will be responsible for completing all documentation relevant to installation, service, repair and rework in compliance with FDA “Good Documentation Practice” and “Good Manufacturing Practice”.
Listed below are the key responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally inclusive, and the person will be expected to complete additional tasks reasonably requested.
Major Responsibilities
Under direction from the Director of Field Service Engineering and Snr. Field Service Engineer , the Field Service Engineer – United States will be responsible for:
- Organizing and providing on-site service and repair of the OrganOx metra device:
- Travelling to hospitals and research facilities within United States.
- Carrying out on-site routine maintenance procedures and liaising directly with customers regarding organizing routine services and other maintenance needs of OrganOx devices.
- Carrying out on-site or back-to-base troubleshooting and re-work of OrganOx devices.
- Carrying out Installation Testing, Post-Rework Soak and Acceptance Testing and completing all documentation in compliance with Good Documentation Practice and the OrganOx Quality Management System.
- Ensuring work orders and service visits are completed within set time frames.
- Assisting with major back-to-base repairs or device upgrades in OrganOx USA workshop, when necessary.
- Short-term covering for the urgent technical needs of devices placed outside United States when the engineer assigned for that region is not available.
- Working with the Snr. Field Service Engineer to maintain a stock of spare parts and consumables necessary for the technical support of the devices within United States.
- Managing a local spare part stock in a local facility and trunk stock within United States under the guidance of the Director of Field Service Engineering .
- Managing and maintenance, including recalibration, of various test equipment, battery calibrators, tools and accessories required during providing technical service within United States.
- Complete technical documentation as required under the regulatory frameworks and standards for medical devices
- Completing technical reports to a high standard.
- To assist the Product Support Manager in maintaining the technical documentation and device history records.
- Ensure that vendor credentialing requirements are current
Skills and Experience
The Field Service Engineer – United States will have:
- Three years or more industry experience servicing and repairing Medical Devices or other complex critical devices.
- A strong and broad working knowledge of electrical and mechanical engineering systems.
- A good track record of demonstrating analytical problem-solving skills.
- Enthusiasm, good communication skills and ability to work effectively in a multi-disciplinary team.
- Ability to produce Technical Reports to a high standard both in terms of technical content, presentation and written English.
- Freedom to travel within United States to carry out servicing, repairs, trouble shooting, and other device maintenance activities as required.
- Commitment to travel with a short notice and to stay away from home for several consecutive days at a time. Travel and onsite servicing will average 80% of working time; this could potentially increase to 90% of working time during specific peaks of activity (such as deployment of fleet-wide upgrades).
- Willingness to work unsocial hours, including weekends and public holidays, when necessary to support customer needs.
- Possession of a Driving License with ability of driving within the United States of America and ability to use company funded rental vehicles.
- Good written and verbal communication skills in English. (essential).
- Be friendly, approachable, and have excellent interpersonal skills
- Be prepared to accept a high degree of responsibility.
- Highly observant of people and procedures.
- Have an analytical approach to problem solving.
- Be willing to work alone within hospital/laboratory environments
- Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies.
Qualifications
The Field Service Engineer-United States will have:
- Associate's degree required; Bachelor's degree or equivalent preferred in electrical, electronic, mechanical or biomedical engineering, or other relevant discipline (essential)
- A good understanding of complex electro-mechanical systems and software (essential)
- Excellent knowledge of key office software, including Excel, Word and PowerPoint (essential)
- Good hands-on experience with a broad range of test equipment, including oscilloscopes, spectrum analyzers and data loggers (essential)
- Prior experience servicing, repairing, testing, and trouble-shooting medical devices within hospitals environments and research facilities (desirable)
- Experience of working with Safety and Quality Standards applicable to medical devices (desirable).
- Geographically located within assigned territory 45 minutes from a major airport (essential).
- Ability to lift and carry 50lbs (essential)
A job description does not imply that the duties stated are the only ones to be performed by the job holder. Employees will be required to follow any other job-related instruction as requested by their manager.
WHAT WE OFFER:
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.