Medical Device Integration Specialist

1 month ago


Durham, United States HemoSonics, LLC Full time
Job DescriptionJob DescriptionDescription:

HemoSonics, LLC is a fantastic organization making life-changing differences for our Patients. Your role as Medical Device Integration Specialist is critical in the successful delivery of our product to our customers and their staff. Best benefits you can find and a positive work environment with supportive teams for your success If you want to help move the world of Blood Management forward, COME JOIN US, YOUR NEW TEAM IS WAITING


The Integration Specialist is responsible for ensuring successful connectivity of our Quantra instruments and accompanying software to hospital IT infrastructure.


WHAT WILL YOU DO IN THE ROLE?

  • Coordinate and manage all appropriate activities related to successful implementation of Quantra’s integration with hospital informatic systems.
  • Complete Quantra IT/Connectivity documentation as required by current and potential customers.
  • Support Commercial personnel as the Quantra IT/Connectivity subject matter expert before, during and after the sales process.
  • Collaborate with hospital IT and Point-of-Care personnel to configure Quantra connectivity within existing facility POCT/LIS/HIS/EMR infrastructure.
  • Maintain working relationships with third-party POCT/LIS solution vendors for tracking of current and upcoming features and to obtain troubleshooting assistance as needed.
  • Provide technical support for complex connectivity inquiries.
  • Provide training on Quantra connectivity solutions to both hospital staff and HemoSonics commercial teams.
  • Collaborate with the HemoSonics Marketing and Software teams on development/testing/implementation of Quantra connectivity solutions.
  • Collaborate with the HemoSonics Customer Support Team to strengthen and expand repository of customer-facing IT/Connectivity resources.
  • Maintain effective and accurate project documentation.
  • Maintain a high level of accountability – taking ownership of problems and seeing them through to resolution.
  • Other duties as assigned to include technical support coverage at minimum.

COMPETENCIES YOU SHOULD HAVE TO BE SUCCESSFUL:

  • In-depth knowledge of computer networking.
  • Strong problem-solving skills and attention to detail.
  • Demonstrated ability to work with cross-functional teams.
  • Excellent communication skills- the ability to communicate with both technical and non-technical personnel.
  • Ability to multi-task and manage time effectively.
  • Ability to work within and document communications using Arena, HemoSonics’ e-QMS system.
  • Preferable knowledge of medical device connectivity.
  • Preferable knowledge of POCT01-A2 and LIS02-A2 compliance.
  • Preferable knowledge of POCT systems infrastructure and message routing systems.
  • Preferable knowledge of hospital network security, including HIPAA and data security considerations.
  • Preferable knowledge of operation within an FDA-regulated medical device environment.

EDUCATION & EXPERIENCE REQUIREMENTS

  • Bachelor’s degree in computer science, Computer Engineering, or related field.
  • Minimum 3 years’ experience in a customer-facing role.
  • Experience working within FDA/ISO Quality Management System.
  • Experience with middleware connectivity of medical devices to hospital POCT/LIS/HIS/EMR preferred.
  • Equivalent combination of skills listed above and experience.

OTHER REQUIREMENTS OF THE ROLE:

The physical demands described here are representative of those that must be met by an employee to

successfully perform the essential functions of the job. Reasonable accommodations may be made to

enable individuals with disabilities to perform the essential functions.

  • This position is primarily based out of the company Headquarters in Durham, NC.
  • This position may include Domestic US travel as needed, up to 50%.

While performing the duties of this job, the employee is regularly required to:

  • Complete all company required training that is specified for the role, as defined by our compliance and training processes and protocols, which may be job specific or corporate/compliance related.
  • Listen and communicate using both verbal and written feedback. Must be able to exchange accurate information in these situations.
  • Maintain a high level of consistent cognitive function.
  • Perform consistent keyboarding/computer use in a typical office environment for extended periods of time, up to 8 hours per day.
  • Frequently move about the office.
  • Stoop, kneel or crouch when maneuvering the office environment.
  • Perform work at customer sites in clinical and/or laboratory environments for extended periods of time, up to 8 hours per day.
  • Lift up to 50lbs at times.
  • Be accessible for contact by phone
  • Maintain a valid US Driver’s License with sufficient documentation required for travel within the US.
  • Drive a vehicle and/or use other travel means as needed when travelling for company business.
  • Be fully vaccinated against Covid-19 or meet the requirements for a medical or religious exemption.

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions and perform any other duties, as assigned by their manager.

Requirements:




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