Senior Engineer, R&D

Edwards Lifesciences • Irvine, CA

4d

About The Position

Edwards is seeking an experienced medical device engineer to join its R&D Engineering team and help design and develop heart valve systems. The role applies Finite Element Analysis (FEA) and develops test methods for transcatheter heart valve (THV) frames, access systems, and delivery systems using bench and simulation modalities. The work supports the company’s strategic plan and addresses unmet clinical needs in structural heart disease.

The engineer will collaborate with Clinical Development and other R&D partners on patient-anatomy Statistical Shape Models and boundary conditions, lead development of FEA models for access and delivery products, and support FEA work on THV frames. The role also leads 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. It involves developing clinically accurate test methods, testing non-metal components, supporting sustaining activities, solving mechanical engineering problems from component to system level, and maintaining accurate documentation and technical reports.

The position interfaces with R&D, manufacturing, clinical development, clinical affairs, quality, and regulatory personnel to support compliance with internal and external policies, procedures, QSR, and FDA regulations. It also works with clinical development teams and physician partners in pre-clinical and clinical environments and requires knowledge of cardiovascular anatomy, heart structure, and valve diseases.

Requirements

• Bachelor's degree in an engineering or scientific field and 4 or more years of experience, or a master's degree in an engineering or 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.

Nice To Haves

• 2 or more years of experience in the medical device industry.
• 6 or more years of experience in simulation using commercially available FEA software.
• PhD in Engineering.
• In-depth knowledge of virtual simulation tools such as ANSYS and 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 FEA knowledge 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 of patient anatomy for implants, access systems, and delivery systems.
• Collaborate with Clinical Development and R&D to develop boundary conditions.
• Lead development of FEA models for components and systems for access and delivery system products.
• Support other FEA engineers in developing and modifying FEA 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 and/or reduce conservatism.
• Provide support to the sustaining function as needed.
• Solve mechanical engineering problems at the component and system levels.
• Maintain accurate documentation of results and generate technical reports.
• Maintain current knowledge of competitive technologies and medical, technical, and biomedical developments related to company products and therapies.
• 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 and/or physician partners in pre-clinical and clinical environments.

Benefits

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

What This Job Offers

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