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.

RESPONSIBILITY AND AUTHORITY

This position is responsible for the planning and execution of validation activities in product development, supporting post-market / sustaining initiatives as well as new products in development. 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.
 

PRIMARY ACTIVITIES

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

• Develop informal and formal usability validation plans for incorporation in the project plan of a new product/feature, or for post-market improvements.

• 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 and maintain usage risk documentation throughout the product life cycle

• Work with the labeling team to develop instructions for use.

• Author protocols and arrange/execute formal usability validation with actual or representative users 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 advanced product support for clinical technical support.

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

• Assist with submissions to regulatory agencies.

• Ensure compliance with regulatory requirements.

• Performs other duties as required by supervisor to support company goals and objectives.

TRAVEL REQUIREMENTS

• This position may require moderate business travel of 20% or more of the time.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Bachelor’s degree in engineering, preferably in biomedical, electrical, biomaterials, or computer science

• 3-5 years of experience with product development and usability engineering

• Knowledgeable in design controls, risk management and post market surveillance

• Experience working with class III medical devices or connected care products

• Demonstrated experience applying risk management practices to the product development process

• Demonstrated experience with authoring design validation protocols, executing validation testing and writing validation reports.

• Experience supporting technical reviews for regulatory submissions and quality investigations

PREFERRED QUALIFICATIONS

• Experience working with external research organizations in preclinical or clinical research.

• Experience with Matlab, COMSOL or other simulation tools

• Experience conducting literature reviews

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $80,000- $100,000 + discretionary annual bonus. Pay ranges may vary by location.

Employee benefits include:

• Health benefits – Medical, Dental, Vision

• Personal and Vacation Time