Senior Engineer, R&D

Edwards Lifesciences • Irvine, CA

23h • $108,000 - $153,000

About The Position

Edwards’ R&D Engineering team develops medical innovations for structural heart disease, working closely with Quality and Manufacturing. In the Transcatheter Heart Valve business unit, this role supports the design and development of heart valve systems, including transcatheter aortic heart valve replacement products, in support of the company’s strategic plan.

The engineer applies finite element analysis (FEA) and develops test methods for transcatheter heart valve frames, access systems, and delivery systems using bench and simulation methods. The role collaborates with Clinical Development and other R&D teams to develop statistical shape models of patient anatomy and boundary conditions; leads FEA model development for access and delivery system products; and supports FEA work on THV frames. It also leads development of virtual and bench models, including sample holders, clinically accurate compliant aortic roots and vessels, CAD, and manufacturing methods.

The position develops test methods for clinically accurate boundary conditions, supports testing of non-metal components such as tissue, polymer, and fabric, and seeks new methods and procedures to accelerate innovation or reduce conservatism. The engineer solves mechanical engineering problems from component to system level, supports sustaining work as needed, documents results, and prepares technical reports. The role maintains knowledge of competitive technologies and medical, technical, and biomedical developments related to company products and therapies.

The engineer works with R&D, Manufacturing, Clinical Development, Clinical Affairs, Quality, and Regulatory personnel to support compliance with internal and external policies and procedures, QSR, and FDA regulations. The role also works with clinical development teams and/or physician partners in pre-clinical and clinical environments, requiring knowledge and understanding of cardiovascular anatomy, heart structure, and valve diseases.

Requirements

• Bachelor’s degree in Engineering or a scientific field and 4 or more years of experience, or a Master’s degree in Engineering or a scientific field and 3 or more years of experience.
• Strong documentation skills, technical writing ability, and verbal communication skills.
• Effective communication, listening, and diagnostic skills.
• Ability to work independently and as a team member.
• Knowledge and understanding of cardiovascular anatomy, heart structure, and valve diseases.

Nice To Haves

• 2 or more years of experience in the medical device industry.
• 6 or more years of experience in FEA simulation using commercially available software.
• Ph.D. in Engineering.
• In-depth knowledge of virtual simulation tools such as ANSYS or ABAQUS.
• Patient CT reconstruction experience using commercial software such as Materialise or Simpleware.
• Hands-on experience with bench fixtures and model building.
• Understanding of ISO, ASTM, and other relevant standards for system testing.
• Understanding of ASME V&V 40.
• Strong understanding of statistical techniques for data analysis and experience with statistical and programming software such as MATLAB or Minitab.
• Experience with non-linear materials such as tissue and hyperelastic materials.
• Cardiovascular experience.
• Prior experience with submissions to the FDA and other regulatory bodies.

Responsibilities

• Apply finite element analysis (FEA) and develop test methods for THV frames, access systems, and delivery systems using bench and simulation modalities.
• Collaborate with Clinical Development to develop statistical shape models for patient anatomy related to implants, access, and delivery systems.
• Collaborate with Clinical Development and R&D to develop boundary conditions.
• Lead development of FEA models for access and delivery system components and products.
• Support other FEA engineers developing or modifying FEA models for THV frames.
• Lead development of virtual and bench models, including sample holders, clinically accurate compliant aortic roots and vessels, CAD, and manufacturing methods such as machining and molding.
• Lead test method development for clinically accurate boundary conditions.
• Collaborate with other groups to test non-metal components, including tissue, polymer, and fabric.
• Develop new test methods or procedures to increase innovation speed or reduce conservatism.
• Provide sustaining-function support as needed.
• Solve mechanical engineering problems at component and system levels.
• Maintain accurate documentation and generate technical reports.
• Maintain current knowledge of competitive technologies and relevant medical, technical, and biomedical developments.
• Interface with R&D, Manufacturing, Clinical Development, Clinical Affairs, Quality, and Regulatory personnel to support compliance with policies, procedures, QSR, and FDA regulations.
• Work with clinical development teams and/or physician partners in pre-clinical and clinical environments.

Benefits

• Competitive salaries
• Performance-based incentives
• A wide variety of benefits programs to address employees’ and their families’ diverse individual needs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior