As a member of the Service and Logistics team, the Field Service Engineer is responsible for providing technical expertise and support to colleagues, current clinical trial sites, customers and/or potential customers. Works under general direction of the Director of Service and Logistics and with Service teammates to install, service, and support clinical sites during a large pivotal FDA clinical trial within the assigned geography. Performs work that involves a high degree of independence. Exercises independent judgment in planning, organizing, and performing work. Seeks to continually improve servicing capabilities.
Provide proactive customer and technical support, installation, repair, and training services to customers on-site and remotely.
Accurately document service activities per ALung’s procedures.
After hours call support and activities.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, clinical sites, contractors, and vendors.
Ideal candidate will be comfortable and competent with handling authority and making decisions.
Support internal customers such as engineering and manufacturing.
Performs other related duties and responsibilities, on occasion, as assigned. Candidate will be an individual contributor with potential for advancement as company grows.
Must be fluent in English.
Technical degree in a field such as electronics, computer science, applied technology, etc.
Proven experience in the field will be considered in lieu of education.
A minimum of five years industrial experience in medical devices servicing is required (FDA and/or EU standards).
High level of technical expertise in computer hardware/software, electronics, and mechanical systems.
Results oriented self-starter who can identify necessary goals and actively pursue them.
Strong analytical skills, writing skills, communication skills and attention to detail required.
Excellent organizational, time management and prioritizing skills. Must demonstrate the ability to manage multiple tasks, prioritize, and meet deadlines in a disciplined, well-organized manner.
Excellent interpersonal verbal, written and presentation skills with ability to effectively communicate at multiple levels and to large groups within and outside the organization.
Capable of building strong working relationships with internal/external customers.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Ability to leverage and/or engage others to accomplish projects.
Strong sense of urgency.
Capable of working unpredictable schedule that may occasionally change on short notice due to patient changes and or physician delays.
Ability to travel up to 75% within assigned region and/or outside assigned region including international locations.
Job activities require mobility and stamina involving a significant amount of walking, standing climbing stairs and sitting; manual dexterity to carry, reach, manipulate, handle and demonstrate company products as well as to write, telephone, use computer keyboard, etc.; stooping and kneeling to pick up and carry equipment; and the ability to communicate clearly. Lifting requirements are normally up to 25 pounds but may exceed that on occasion.
Works with cellular phone, personal computer, and product line technology. Has responsibility for field service tool kit and spare part kits. Operates a motor vehicle for trips to various company sites and outside vendor, field, and customer locations; and to commute to various airports for airline travel.
Work environment varies from office/field including physician offices, procedure rooms and hospital operation rooms, intensive care units with a low to moderate noise level to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc.
ALung Technologies, Inc. is a privately-held Pittsburgh-based developer and manufacturer of innovative lung assist devices. Founded in 1997 as a spin-out of the University of Pittsburgh, ALung has developed the Hemolung RAS as a dialysis-like alternative or supplement to mechanical ventilation. ALung is backed by Philips, UPMC Enterprises, Abiomed, The Accelerator Fund, Allos Ventures, Birchmere V...entures, Blue Tree Ventures, Eagle Ventures, Riverfront Ventures, West Capital Advisors, and other individual investors.