Location: Philadelphia,PA, USA
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 4,000 liver transplant operations globally, optimizing the use of donated organs by enabling assessment of the quality of livers as well as longer preservation durations. As part of our ongoing expansion, we seek a Product Support Engineer to join our team.
POSITION SUMMARY:
The Product Support Engineer-North America will be primarily responsible for the on-site service and repair of complex electro-mechanical medical devices designed for organ preservation placed within North America region. Reporting to the Sr. Product Support Engineer, the postholder will be responsible for providing technical support for OrganOx metra retained units placed in North America to ensure that product reliability, quality and availability are maintained. The Product Support Engineer – North America 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”.
This position will be remote in either Philadelphia PA or Boston MA.
KEY RESPONSIBILITIES:
Under direction from the National Director of Field Service Engineering, the Product Support Engineer will be responsible for:
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 by the Product Support Manager.
1. Organizing and providing on-site service and repair of the OrganOx metra device.
a. Travelling to hospitals and research facilities within North America, including The United States of America and Canada.
b. Carrying out on-site routine maintenance procedures and liaising directly with customers regarding organizing routine services and other maintenance needs of OrganOx devices.
c. Carrying out on-site or back-to-base root cause investigations and re-work of OrganOx devices.
d. 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.
e. Ensuring work orders and service visits are completed within set time frames.
f. Assisting with major back-to-base repairs or device upgrades in OrganOx USA workshop, when necessary.
g. Short-term covering for the urgent technical needs of devices placed outside North America when the engineer assigned for that region is not available.
h. Working with the Snr. Product Support Engineer to maintain a stock of spare parts and consumables necessary for the technical support of the devices within North America.
i. Managing a local spare part stock in a local facility within North America under the guidance of Product Support Manager.
j. Managing and maintenance, including recalibration, of various test equipment, battery calibrators, tools and accessories required during providing technical service within North American region.
2. Complete technical documentation as required under the regulatory frameworks and standards for medical devices
a. Completing technical reports to a high standard.
b. Assist the Product Support Manager in maintaining the technical documentation and device history records.
c. Ensure that vendor credentialing requirements are current.
d. Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies.
Requirements
SKILLS AND EXPERIENCE:
· 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 North America 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 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 Canada.
· 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
QUALIFICATIONS:
· Bachelor's degree or equivalent work experience 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).
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
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.