Product Support Engineer

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 the North America region.   Reporting to the Product Support Manager, the post holder will be responsible for providing technical support for the 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”.

Major Responsibilities:

1. Organizing and providing on-site service and repair of the Company device:
   1. Traveling to hospitals and research facilities within North America, including The United States of America and Canada.
   2. Carrying out on-site routine maintenance procedures and liaising directly with customers regarding organizing routine services and other maintenance needs of Company devices.
   3. Carrying out on-site or back-to-base root cause investigations and re-work of Company devices.
   4. Carrying out Installation Testing, Post-Rework Soak, and Acceptance Testing and completing all documentation in compliance with Good Documentation Practice and the Quality Management System.
   5. Ensuring work orders and service visits are completed within set time frames.
   6. Assisting with major back-to-base repairs or device upgrades in the USA workshop, when necessary.
   7. Short-term covering for the urgent technical needs of devices placed outside North America when the engineer assigned for that region is not available.
   8. Working with the Product Support Manager to maintain a stock of spare parts and consumables necessary for the technical support of the devices within North America.
   1. Managing a local spare part stock in a local facility within North America under the guidance of the Product Support Manager.
   10. Managing and maintaining, including recalibration, of various test equipment, battery calibrators, tools, and accessories required during providing technical service within the North American region.
2. Complete technical documentation as required under the regulatory frameworks and standards for medical devices
   1. Completing technical reports to a high standard.
   2. To assist the Product Support Manager in maintaining the technical documentation and device history records.
   3. Ensure that vendor credentialing requirements are current

Skills and Experience:

• Three years or more of industry experience servicing and repairing Medical Devices or other complex critical devices.
• 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, 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 will average 60% of working time; this could potentially increase to 80% of working time during specific peaks of activity (such as the 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 the ability to drive 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 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 troubleshooting medical devices within hospitals environments and research facilities (desirable)
• Experience in working with Safety and Quality Standards applicable to medical devices (desirable).