Clinical Engineer, R&D

Join us today and make a difference in people's lives!
 

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

This position is responsible for activities in product development and the planning and execution of clinical (human) and pre-clinical (animal) studies.  Clinical Engineers work with project teams to establish user needs for new products or enhancements; develop design validation plans; analyze product risks; and manage the execution of both informal and formal design validation with a focus on usability engineering.  In addition, Clinical Engineers serve as the primary technical support organization during premarket clinical studies of investigational devices.  This function includes the preparation of and conduction of device training of investigational sites and monitors, as well as real-time troubleshooting support.  May include travel for education, implantation and study support for product users or clinical study sites.
 

PRIMARY ACTIVITIES

• Support product development team in the determination of testable system level requirements (user needs) for new products/features.

• Develop informal and formal usability validation plans for incorporation in the project plan of a new product or feature.

• Conduct face to face interviews with product users, assess cognitive workflow adequacy, and analyze task execution of users (formative evaluations).

• Assess use-risk throughout the development cycle of a new product or feature as part of risk analysis

• Work with project team to develop instructions for use.

• Author protocols and arrange/execute formal usability validation with actual users (or representative) to demonstrate usage requirements are met and appropriate usage controls have been implemented.

• Author design validation reports

• Author Human Factors Engineering report at the conclusion of the project to summarize all aspects of usability engineering conducted throughout the development/validation cycle of the product to support submission to regulatory bodies.

• Research the feasibility of new products or new product indications including protocol development and support for pre-clinical pilot studies

• Facilitate animal research for feasibility or GLP studies for development for evaluation of new products or enhancements to existing products as applicable.

• Provide technical support for clinical studies.

• Advanced product support for clinical technical support.

• Assist in clinical study and post-market study support as necessary.

• Travel to sites for technical and implantation support as necessary.

• Manage company-approved non-clinical extramural studies involving VNS equipment provided to independent researchers.

• Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.

• Provide clinical engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.

• Analyze and prepare reports of clinical data as needed.

• Interact with current and prospective investigators and study coordinators.

• Assist with submissions to regulatory agencies.

• Ensure compliance with regulatory requirements.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Engineering Degree (preferably Biomedical, Electrical, or Clinical)

• MS Office proficient

• Good written and verbal communication skills

• The minimum requirements, skills and qualifications contained in this job description outline the core functions and requirements of the position and do not constitute an exhaustive listing of activities, duties, or responsibilities that may be required of or assigned to an employee in this position at the Company’s discretion. Further, the ability to meet the minimum requirements and/or possession of the stated skills and qualifications do not imply or establish that an individual will be employed in this position.

Employee benefits include:

·       Health benefits – Medical, Dental, Vision

·       Personal and Vacation Time

·       Retirement &a