Job Details

Job Description

Field Service Engineer Position
Santa Barbara CA analytical medical device company is recruiting a field service and support engineer. This is a critical role where you will travel to support deployment, installation, and support of new IVD2 medical product to hospitals and laboratories as well as maintain in-house device installations. We are an emerging medical device company that is changing healthcare and will save lives. We are looking for a self-starter to deliver exceptional customer service experience. The expectation is to drive service success and product reliability to maintain a persistent high level of customer satisfaction.
We have completed clinical trials and are in the FDA review process. After receiving FDA approval, we will aggressively commercialize the product.
Your primary responsibilities will include:

• Product Service
  • Develop relationships with hospital customer personnel to coordinate new product installations and ongoing support
  • Prepare product, arrange shipping to site, meet product upon site arrival, and install system in hospital environment
  • Visit sites to perform scheduled periodic maintenance. This includes performing calibration, component replacement, software upgrades, testing and verification, documentation, and address any customer concerns
  • Provide technical service for non-scheduled customer calls when site problems occur. This includes user issues and system malfunctions. Determine/implement best solution for customer satisfaction
  • Taking customer support calls and emails, customer training, walk through troubleshooting, remote access to device, deep troubleshooting, and possibly travel to site to remedy issues. Customer satisfaction is the supreme goal
  • Anticipate issues and remedy before hardware failure
  • Prepare medical device systems in-house, perform qualifications, nurture delivery to sites
  • Identify common failure modes and develop improvements through quality, hardware, and software change suggestions
  • Represent the customers' interests to inform the development of new software changes
  • Be friendly and responsive to all customer complaints
• Documentation
  • Understand and follow all Standard Operating Procedures as described in the Quality Management System
  • Documentation is a critical requirement for FDA approved medical devices. You will be responsible for completing existing documentation, checklists, forms, reviewing and authoring procedures, and ushering documentation finalization following a defined quality system
  • Design and create procedures to improve efficiency and to simplify any process or flow
  • Maintain record of all instruments, periodic maintenance schedule, failures, critical site contacts, and general service visit schedule
  • Maintain or create inventory record
• Hardware Supply Chain
  • You will work with the device Contract Manufacturers to schedule delivery and receiving, perform receiving inspections, and provide quality feedback throughout the process for continuous improvement
  • Maintain physical inventory and order components to support service requirements

Knowledge, Skills, and Abilities:

• Excellent system level troubleshooter in electrical, optical, mechanical, PC-based computer, and fluidic/pneumatic systems
• Ability to test, analyze, and repair equipment
• Knowledge of PC computer architecture, electronic theory, electronic test equipment, and fluidic/pneumatic/electronic/mechanical/optical custom systems
• Familiar with electronic and fluidic system diagrams
• Skilled with hand and lab tools - drivers, wrenches, sockets, torquing tools, DVM, thermometer, and custom calibration tooling
• Knowledge of general software tools including Microsoft Office Suite including Outlook e-mail, database management, Excel, and Word. Ability and eager to learn new tools
• Meticulous record keeping and eagerness to maintain FDA mandatory device history documentation

• Highly organized and self-motivated
• Creates and maintains excellent relationships with customers and staff
• Excellent phone communication etiquette

• Ability to lift up to 50 pounds of equipment; to push/pull equipment carts; and to kneel, stand, bend, and reach during equipment repair
• Ability to travel extensively up to 80% of weekly hours
• Genuine interest in constant process improvement
• Demonstrate technical proficiency on product subsystems as needed for support responsibilities
• Excellent customer-facing communication skills - written, phone, and face-to-face
• Experience working in an ISO 13485 and/or ISO 9001 environment greatly improves qualification

Qualifications

• Education/Experience -BA/BS degree or higher in electronics, mechanical engineering, physics or related technology preferred
• Work experience - preferred minimum 2 years hands-on experience in relevant training or job
• An equivalent combination of experience and education may be substituted
• Need to be local to primary office location of Santa Barbara, CA

Company offers competitive salary and benefits including health insurance, paid vacation, and a matching 401(k) plan. This is an excellent opportunity to immerse yourself in the medical device industry and FDA environment. This position is for immediate filling, and we look forward receiving your qualified resume!
Salaried compensation based on experience and qualifications.

Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.

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