Biomedical Engineer - Heart Institute

$166,130 - $166,130/Yr

Cedars-Sinai - Los Angeles, CA

Full-time - Mid Level

Los Angeles, CA

Hospitals

About the position

The Biomedical Engineer at Cedars-Sinai's Heart Institute is responsible for the development and delivery of biomedical programs and products, particularly focusing on transcatheter heart valves and related components. This role encompasses all phases of the development lifecycle, including conception, design, testing, production, and maintenance, while ensuring compliance with regulatory standards. The engineer will collaborate with cross-functional teams, mentor junior staff, and serve as a liaison between various stakeholders to achieve project milestones.

Responsibilities

• Functions as the single point of contact to a cross-functional team.
• Responsible for the development and delivery lifecycle during the following phases: Requirement Assessment, Development, Testing, and Delivery.
• Works with inter-departmental teams to analyze and understand business requirements and documents new requirements.
• Develops functionality based on requirements, following internal development standards.
• Performs unit, regression, connectivity, and full end-to-end integration tests.
• Collaborates with resources to migrate new or enhanced functionality from test to production.
• Acts as a liaison with end users, research groups, and other business support areas.
• Leads the design and development of a program/application/product.
• Facilitates design and technical meetings and provides technical documentation.
• Instructs, guides, and mentors junior-level staff.
• Provides support during special events such as mission-critical upgrades/enhancements.
• Develops and implements policies for security and confidentiality of program/application/product.
• Performs mechanical design, development, and testing of a transcatheter heart valve.

Requirements

• Bachelor's degree in Computer Science, Mathematics, Engineering, or related discipline required.
• Master's Degree in Engineering or similar field preferred.
• 4-5 years of experience managing design, development, and maintenance in a complex, multiplatform environment required.
• 10 years' experience developing structural heart products and/or product design preferred.
• 10 years' experience using 3D model software preferred.
• Knowledge of FDA Quality System Regulations, Medical Device Directives including ISO 13485, ISO 14971, and ISO 62304 standards.
• Ability to use structural finite element analysis software such as Cosmos or Ansys.
• Demonstrate data analysis skills and sound statistical analysis methodologies.

Nice-to-haves

• AWS Certified Solutions Architect - Associate
• AWS Certified Developer Associate
• Experience with Minitab, JMP or MedStat for data analysis.