Senior Principal Engineer, R&D

Edwards Lifesciences; Irvine (CA); On-site; USD 156,000 - 221,000; Full time

Job summary

An established industry player is seeking a Senior Principal Engineer to lead innovative projects in the Transcatheter Heart Valve sector. This role requires a deep understanding of materials science, particularly implantable metal alloys, and hands-on experience in mechanical testing. You will collaborate with cross-functional teams to enhance testing methodologies and ensure compliance with regulatory standards. If you're passionate about advancing medical technology and improving patient outcomes, this is a unique opportunity to make a significant impact in a dynamic environment.

Benefits

Competitive Salaries

Performance-Based Incentives

Diverse Benefits Programs

Qualifications

• 8+ years in medical device engineering or highly regulated industry.
• In-depth knowledge of metal alloys and their behaviors.
• Hands-on experience with mechanical and fatigue testing.

Responsibilities

• Lead studies to improve testing setups and execute material testing.
• Mentor engineers and technicians in testing and documentation.
• Interface with R&D and regulatory personnel for compliance.

Skills

Implantable Metal Alloys Knowledge

Fatigue Testing

Mechanical Testing

Materials Characterization

Statistical Techniques

Effective Communication

Education

Bachelor's in Mechanical Engineering

Master's in Mechanical Engineering

PhD in Relevant Field

Tools

SEM

Minitab

MATLAB

Job description

Innovation starts from the heart. At Edwards, we put patients first. 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.

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.

This is an exceptional opportunity for an experienced medical device engineer with technical expertise to contribute to the cutting edge Transcatheter Heart Valve programs. The Senior Principal Engineer will be a technical expert responsible for all material characterization and testing with focus on metals testing including acute and chronic or fatigue testing as part of a team to design and develop of heart valve or components in support of company's strategic plan.

How you’ll make an impact:

• Lead studies to assess existing test setups for any improvement, plan and execute testing at material level, for example uniaxial testing, development of constant lifeline for fatigue etc.

• Lead studies to assess existing test setups for any improvement, plan and execute testing at device level, for example radial force testing, crush testing, fatigue test to success etc.

• Work with project teams as a subject matter expert (SME) to define appropriate design/material requirements and select the best material for the application

• Challenge status quo to develop new test methods and/or procedures to increase speed of innovation and/or to reduce conservatism

• Be an SME in communication with regulatory bodies

• Mentor other engineers and technicians

• Apply biomedical and mechanical engineering principles to the evaluation of new products for the Transcatheter Heart Valve market

• Provide support to sustaining function as needed (either as an SME mentor or a team member)

• Responsible for working with a lab manager to maintain state of the art equipment like fatigue testers by TA ELF, MTS, Sysmetric etc, acute testers by Instron etc

• Possess knowledge of SEM/EDX analysis, HAZ analysis, microstructure analysis, transformation temperature testing (DSC), Auger analysis, XRD analysis, etc.

• 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 mechanical or materials engineering with 8+ years of experience in the medical device industry or a highly regulated industry - OR

• Master's degree in mechanical or materials engineering with 7+ years of experience in the medical device industry or a highly regulated industry

• In-depth knowledge of implantable metal alloys (e.g. Nitinol, Stainless Steel, Cobalt Chromium, Titanium) as it relates to materials science, material fatigue, corrosion behavior, materials characterization, stress & failure analysis, etc.

• Hands-on experience with fatigue, fracture and mechanical testing, SEM, metallography and microstructure analysis, experience working in a laboratory

What else we look for (Preferred):

• Effective communication, listening, and diagnostic skills

• The ability to work well independently and as a team member

• A master’s degree or PhD

• Understanding of ISO, ASTM and other relevant standards for device and metals testing

• Strong understanding of statistical techniques, especially applied to fatigue data analysis and experience with statistical and programming software such as MATLAB, Minitab etc.

• Experience with non-linear materials like tissue, hyperelastic, Nitinol etc. experience

• Cardiovascular experience

• Strong documentation skills; strong technical writing ability and good verbal communication skills

• Prior experience with submissions to FDA and other regulatory bodies is helpful

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.

For California (CA), the base pay range for this position is $156,000 to $221,000 (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.