Senior BioMedical Engineer

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. 

Position Title: Senior Biomedical Engineer

Location: Remote out of Grand Rapids, MI

Position Summary:

The Cardiopulmonary Business unit has a unique portfolio of leading cardiopulmonary products that are used to treat millions of patients worldwide. Through a complete range of cardiopulmonary equipment and disposables led by the worlds #1 heart lung machine, LivaNova has been offering customer centric integrated perfusion solutions for decades. We are taking the next step in our commitment to innovation and development of perfusion practice with the launch of the completely redesigned Essenz Perfusion system. The Essenz Perfusion System is built on a 50-year legacy of trusted partnerships with perfusionists. It is designed to meet evolving standards of safety and reliability to deliver lifesaving care to patients.

As a member of the Specialty Cannula Engineering team, the Senior Biomedical Engineer is a key leadership role in the development and maintenance of Cardiopulmonary disposables products including Cannulas. The Senior Biomedical Engineer works under the direction of Engineering Managers and with engineering team members.  The Senior Biomedical Engineer:

• Manages complex technical projects and interfaces across functional groups within the company.
• Performs work that involves a high degree of independence.
• Exercises independent judgment in planning, organizing, and performing work.
• Seeks to continually improve project management and development efficiency.

General Responsibilities:

• Lead the development of medical devices including planning, design, analysis, testing and reporting. Establish and update product development deliverables.
• Manage cross functional team meetings with tracking and accountability for action plans and deliverables.
• Develop, manage, and execute development programs including mechanical, biological, and functional testing of medical devices.
• Analyze experimental data and write test reports.
• Serve as a technical leader and subject matter expert within LivaNova Cardiopulmonary.
• Run brainstorming and problem solving activities.
• Utilize creativity, knowledge and research to solve complex design and customer challenges.
• Set design goals and specifications for product development efforts.
• Provide engineering support for manufacturing, quality, and regulatory activities. This will include sustaining engineering efforts, regulatory support for submissions and changes, and complaint resolution.
• Provides leadership, mentorship and occasional management for entry level engineers or peers.
• Interface with external firms and suppliers (design and contract manufacturers) regarding sourcing and purchasing supplies and services. 
• Lead all aspects of pre-clinical testing, including but not limited to, biocompatibility, sterility, animal testing, packaging, reliability, and performance.
• Provide written status updates to Managers as required.
• Understand and apply knowledge of product line and clinical applications to work activities.

Skills and Experience:

• Understanding and experience developing Class II / Class III medical products within a regulated environment, including design controls, risk management, quality management systems, and regulatory compliance.
• Strong analytical and writing skills as well as a strong attention to detail and organization are required.
• Experience in performing biocompatibility testing, animal model testing and dynamic blood flow testing is preferred.
• CAD design skills (SolidWorks).
• Must be proficient in Microsoft Office Suite products. Proficient in file sharing platforms like BOX and Sharepoint.
• Must be able to communicate ideas and information clearly, effectively, and frequently (oral and written) with program team and throughout the company. Manage cross functional development programs including direction to other departments.
• Ability to work within a regulated environment and follow appropriate procedures and standards.
• Knowledge of the fundamental principles of mechanics.
• Knowledge of the fundamental principles of fluid mechanics.
• Knowledge of physiology, polymer materials science, and fluids is preferred.

Education:

• Bachelor’s degree in biomedical engineering, Bioengineering, Chemic