Senior Engineer, R&D

Edwards; Irvine (CA); On-site; USD 108,000 - 153,000; Full time

Benefits offered by this job

Competitive salary

Performance-based incentives

Benefits package

Job summary

Edwards is seeking an experienced medical device engineer to apply Finite Element Analysis to heart valve systems and associated delivery devices. You will work with Clinical Development and R&D to develop accurate boundary conditions and robust FEA models for THV components.

The role requires strong experience in simulation (ANSYS/ABAQUS), bench testing, and documentation, with knowledge of ISO/FDA guidelines.

Qualifications

• Bachelor’s degree in engineering or related field with 4+ years of experience, or Master’s with 3+ years.
• Experience in Finite Element Analysis and device development is required.
• Proficiency with ANSYS or ABAQUS for complex biomechanical simulations.

Responsibilities

• Develop FEA models for THV frames, access and delivery systems.
• Collaborate with Clinical Development and R&D to set boundary conditions.
• Lead test method development and virtual/bench testing.
• Document results and generate technical reports.
• Ensure compliance with QSR and FDA regulations.
• Support sustaining engineering as needed.

Skills

FEA

ANSYS

ABAQUS

MATLAB

Minitab

Statistical analysis

Cardiovascular knowledge

FDA submissions

Documentation

Bench fixtures

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or scientific field

PhD in engineering (preferred)

Tools

Materialise

Simpleware

Job description

Innovation starts from the heart. At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, you will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open-heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you will make an impact:

This is an exceptional opportunity for an experienced medical device engineer who will apply knowledge of Finite Element Analysis (FEA), test method development for THV frames, access and delivery systems (DS) using bench and simulation modalities as part of a team to design and develop heart valve systems in support of company's strategic plan.

• Collaborate with Clinical Development group to develop Statistical Shape Models for patient anatomy for implant, access and DS.
• Collaborate with Clinical Development group and R&D group to develop boundary conditions.
• Lead effort to develop FEA models for components and systems for access and DS products.
• Support other FEA engineers in developing, modifying FEA for THV frames.
• Lead effort to develop virtual and bench models like sample holders, clinically accurate compliant aortic roots, vessels, CAD and manufacturing (machining, molding).
• Lead test method development for clinically accurate boundary conditions.
• Collaborate with other groups to test non-metal components: tissue, polymer, fabric.
• Challenge status quo to develop new test methods and/or procedures to increase speed of innovation and/or to reduce conservatism.
• Provide support to sustaining function as needed.
• Solve mechanical engineering problems at the component through system level.
• Maintain accurate documentation of results and generate technical reports.
• Maintain current knowledge of competitive technologies in addition to 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 ensure compliance with internal and external policies and procedures, QSR, and FDA regulations.
• Work closely with clinical development and/or physician partners in both a pre-clinical and clinical environment with strong knowledge and understanding of cardiovascular anatomy, structure of the heart, and valve diseases.

What you’ll need (Required):

• Bachelor's Degree in Engineering or Scientific field, 4+ years’ experience - OR -

• Master's Degree in Engineering or Scientific field, 3+ years’ experience

What else we look for (Preferred):

• 2+ years of experience in the medical device industry
• 6+ years of experience in simulation using FEA with commercially available software
• A PhD in Engineering
• In-depth knowledge of virtual simulation tools like ANSYS, ABAQUS etc.
• Prior patient CT reconstruction experience using commercial software such as Materialise, Simpleware etc.Hands-on experience with bench fixture, 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, Minitab etc. is preferred.
• Experience with non-linear materials like tissue, hyperelastic etc. is preferred.
• Cardiovascular experience preferred.
• Strong documentation skills; strong technical writing ability and good verbal communication skills.
• Effective communication, listening, and diagnostic skills are required.
• Prior experience with submissions to FDA and other regulatory bodies is helpful.
• The ability to work well independently and as a team member is essential.

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs

For California, the base pay range for this position is $108,000 to $153,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.