Clinical Application Specialist

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Clinical Application Specialist

April 2021

HemoSonics, LLC is seeking a Clinical Application Specialist who will be responsible for responsible for overall customer and technical support including end-user and/or distributor training, installation, and validation for the Quantra System.

Key Attributes of the Successful Candidate:

  • Thorough knowledge of IVD regulatory guidelines is required
  • An understanding of GLP, GDP, and change control processes
  • Strong organizational skills and attention to detail
  • Effective analytical, quantitative, and problem-solving skills
  • Strong written and verbal communication skills, and the ability to work in a team driven environment are required
  • Ability to function in a fast paced, dynamic work environment
  • Strong computer skills and proficiency in use of MS Excel, PowerPoint, and Word

Key Responsibilities:

  • Support Quantra Installation/Validation at customer sites
    • Schedule / perform instrument installs
    • Train customers to operate Quantra
    • Perform Quantra validations as determined by client need
    • Analyze and review validation data for acceptance
    • Work with customers on CAP, CLIA, and CLSI guidelines for regulatory compliance
    • Establish and maintain positive rapport with customers
    • Troubleshoot problems that may arise while in the field
  • Participate in Sales Training/OUS distributor training as needed to include use of existing training tools and development of new training materials
  • Assist Sales team in calls with potential customers to answer questions from Lab/POC stakeholders
  • Answer phone and email customer/technical support lines for customer queries:
    • Complete necessary Quality Systems documentation
    • Route inquiries and feedback to appropriate departments
    • Participate in on-call rotation to cover after-hours if needed
    • Initiate non-conformances and assist with complaint investigations
    • Work with cross-functional teams for problem resolution
  • Liaise with Field Service to ensure Field Service Engineers have enough detail to perform on site assessment and repair of Quantra
  • Compile customer support data and calculate customer support metrics for Management Review, Post Market Surveillance, and Board presentations
  • Train new Clinical Application Specialists
  • Work with cross-functional teams to develop SOPs, Work Instructions and Forms
  • Record customer information in to include the following:
    • Pre-implementation conference call with new customers
    • Completion of installation
    • Completion of validation to include precision, accuracy, reference range testing and attachment of documentation of each
  • Represent HemoSonics at trade shows, conferences, etc.
    • Perform instrument demos for key opinion leaders, potential customers, parent-company leadership
  • Other duties as assigned including special projects with cross functional teams at HemoSonics

Education and Experience Required:

    • Bachelor’s Degree in Chemistry, Biology or related field and 5 or more years’ experience in medical device specialty, including roles as clinical, technical and/or applications specialist with at least 3 years’ customer-facing experience; or equivalent combination of education and experience

Physical Requirements:

  • Will involve travel to customer sites within the U.S. as needed
  • Must be able to lift/carry up to 50lbs. and sit/stand for extended periods

This position is located in Durham, NC.

To apply, please submit your cover letter, resume and salary requirements to:

HemoSonics, LLC is an equal opportunity employer. All applicants will be considered for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Why HemoSonics?

HemoSonics is a growing team of scientists, engineers, regulatory and business professionals all focused on transforming the way clinicians manage coagulation dysfunctions by providing comprehensive, timely information on coagulation status at the point of care.

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About the Technology

Learn how our unique SEER technology enables a closed-system, vibration resistant device.

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Explore the System

Learn more about the features of our next-gen device designed for the POC and how it empowers clinicians to quickly assess coagulation characteristics.

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