Biomedical Engineer
1 week ago
Job Summary:
As a Biomedical Engineer at Cedars-Sinai, you will play a key role in the design, development, and testing of medical devices, including transcatheter heart valves. You will work closely with cross-functional teams to analyze and understand business requirements, develop technical solutions, and ensure compliance with regulatory standards. Your expertise in structural finite element analysis software, such as Cosmos or Ansys, and your ability to use data analysis skills and sound statistical analysis methodologies will be valuable assets to the team.
Key Responsibilities:
- Function 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.
- Lead the design and development of a program/application/product.
- Facilitate design and technical meetings. Provide technical documentation to internal business and design teams.
- Instruct, guide, and mentor junior-level staff.
- Provide support during special events such as mission-critical upgrades/enhancements, upgrades, new go-lives.
- Develop and implement policies for security and confidentiality of program/application/product.
- Provide support in the role of a backup to other members of the team.
- Perform other duties as assigned or required by management.
Requirements:
- Bachelor's degree in Computer Science, Mathematics, Engineering, or related discipline required.
- Masters Degree in Engineering or similar field preferred.
- AWS Certified Solutions Architect - Associate, or AWS Certified Solution Architect Associate, or AWS Certified Developer Associate, or similar.
- 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 to prepare data for regulatory review (Minitab, JMP or MedStat).
Physical Demands:
Sit at a desk or table with some walking, standing, bending, stooping, or carrying of light objects. Perform continuous operation of a personal computer for four hours or more. Use hands and fingers to handle and manipulate objects and/or operate equipment.
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