Product Support Engineer – Workshop Based

Position Summary:

The Product Support Engineer (workshop-based)-North America will be primarily responsible for the back-to-base service and repair of complex electro-mechanical medical devices designed for organ preservation. Reporting to the Sr. Product Support Engineer, the post holder will be responsible for providing technical support for the company-retained units 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 (Food and Drug Administration) “Good Documentation Practice” and “Good Manufacturing Practice.”  

Major Responsibilities:

Perform Back to Base routine maintenance procedures at the Maintenance Center while communicating with clinical specialists and Product Support Engineers. The Product Support Engineer also performs major back-to-base repairs or device upgrades.

• Maintenance Center, including conducting back-to-base root cause investigations and re-work of devices.
• Assisting with organizing and managing the local spare part stock in our North American facility. Focusing on maintaining an inventory of spare parts and consumables required for providing technical support within North America, all under the guidance of the Sr. Product Support Engineer.
• Maintain and recalibrate various test equipment, battery calibrators, tools, and accessories used for technical service in the North American region.
• Perform Post-Rework Soak and Acceptance Testing and complete all documentation in compliance with Good Documentation Practice and the Quality Management System.
• Occasional travel to hospitals and research facilities within North America, including The United States of America and Canada, this may include Installing a Device in a customer facility.
• Provide short-term coverage for urgent technical needs of devices placed outside North America when the assigned engineer is unavailable.
• Efficiently ensure the timely completion of work orders, service tasks, technical documentation, and high-standard technical reports as required by medical device regulatory frameworks and standards. They also provide valuable support to the Sr. Product Support Engineer in maintaining technical documentation and device history records.
• Maintain and ensure compliance with current vendor credentialing requirements.

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 record of accomplishment, demonstrating analytical problem-solving skills.
• Enthusiasm, effective 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.
• The position is workshop based and although travel will be less frequent, availability to travel within North America to carry out servicing is required, to do repairs, troubleshooting, and other device maintenance activities.
• Commitment to travel with short notice and to stay away from home for several consecutive days at a time.
• Willingness to work during 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 high 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).