Field Service Engineer

OrganOx; Denver (CO); Remote; USD 115,000 - 135,000; Full time

Job summary

A global medical device company is seeking a Field Service Engineer to provide on-site service and repair for their organ preservation devices across the United States. The ideal candidate will possess strong electrical and mechanical engineering skills, a commitment to travel up to 80% of the time, and experience in the medical device industry. This remote role offers a competitive salary and comprehensive benefits from day one.

Benefits

Health insurance

401(k) with company matching

Paid time off

Employee discounts

Qualifications

• 3+ years of industry experience servicing medical devices.
• Strong understanding of complex electro-mechanical systems.
• Ability to lift and carry 50 lbs.

Responsibilities

• On-site service and repair of OrganOx metra devices.
• Travel to hospitals and research facilities.
• Complete technical documentation in compliance with standards.

Skills

Electrical and mechanical engineering systems

Analytical problem-solving

Excellent communication skills

Technical report writing

Interpersonal skills

Education

Associate's degree in relevant engineering field

Tools

Office software (Excel, Word, PowerPoint)

Test equipment (oscilloscopes, analyzers)

Job description

Overview

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 Clinical Training Manager to join our team.

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 National Director of Field Service Engineering, 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.

This is a remote-based position located in the Salt Lake City, UT or Denver, CO area. The incumbent must reside within one of these territories and be located within 45 minutes of a major airport hub to facilitate travel up to 80% of the time.

Responsibilities and requirements described below are indicative, and the person will be expected to complete additional tasks reasonably requested by the Product Support Manager.

Responsibilities

• Under direction from the National Director of Field Service Engineering, the Field Service Engineer – United States will be responsible for on-site service and repair of the OrganOx metra device.
• Organizing and providing on-site service and repair of OrganOx metra devices.
• Traveling to hospitals and research facilities within the United States.
• Carrying out on-site routine maintenance procedures and liaising with customers regarding routine services and other maintenance needs of OrganOx devices.
• Carrying out on-site or back-to-base troubleshooting and re-work of OrganOx devices.
• Performing 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 urgent technical needs of devices outside the United States when the regional engineer is unavailable.
• Maintaining a stock of spare parts and consumables necessary for technical support within the United States.
• Managing local spare part stock in a local facility and trunk stock within the United States under the guidance of the Director of Field Service Engineering.
• Maintenance and recalibration of test equipment, battery calibrators, tools and accessories required for service in the United States.
• Completing technical documentation as required under regulatory frameworks and standards for medical devices, and producing technical reports to a high standard.
• Assisting the Product Support Manager in maintaining technical documentation and device history records.
• Ensuring vendor credentialing requirements are current.
• Adhering to OrganOx Code of Conduct and other company policies.

Qualifications & Skills

The Field Service Engineer – United States will have:

• A strong and broad working knowledge of electrical and mechanical engineering systems.
• A good track record of 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 in terms of content and written English.
• Freedom to travel within the United States to carry out servicing, repairs, troubleshooting, and other device maintenance activities as required.
• Commitment to travel with 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 increase to 90% during peak activity (e.g., fleet upgrades).
• Willingness to work unsocial hours, including weekends and public holidays, when necessary to support customer needs.
• Possession of a Driving License with ability to drive within the United States and use company-funded rental vehicles.
• Good written and verbal communication skills in English (essential).
• Friendly, approachable demeanor with excellent interpersonal skills.
• Willingness to accept a high degree of responsibility and be highly observant of people and procedures.
• Analytical approach to problem solving and ability to work independently in hospital or laboratory environments.

Requirements

• Minimum of an Associate's degree or higher in electrical, electronic, mechanical or biomedical engineering, or another relevant discipline (essential).
• Three years or more of industry experience servicing and repairing medical devices or other complex critical devices (essential).
• Strong understanding of complex electro-mechanical systems and software (essential).
• Excellent knowledge of key office software, including Excel, Word and PowerPoint (essential).
• Experience with a broad range of test equipment (oscilloscopes, spectrum analyzers, data loggers) (essential).
• Prior experience servicing, repairing, testing, and troubleshooting medical devices within hospital environments and research facilities (desirable).
• Experience with Safety and Quality Standards applicable to medical devices (desirable).
• Must be able to commit to travel 80% or more of working time on short notice.
• Geographically located within the assigned territory, within 45 minutes of a major airport (essential).
• Ability to lift and carry 50 lbs (essential).

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.

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Benefits

The Pay Range for this position is $115,000 - $135,000 annually, with a 10% target annual bonus and benefits.

WHAT WE OFFER:

OrganOx offers 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.

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.