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.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 Distinguished 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 12+ years of experience in the medical device industry or a highly regulated industry - OR
Master's degree in mechanical or materials engineering with 10+ years of experience in the medical device industry or a highly regulated industry
In-depth knowledge of Nitinol, Stainless Steel, Cobalt Chromium, Titanium and other implantable metal alloys 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
Effective communication, listening, and diagnostic skills
The ability to work well independently and as a team member
What else we look for (Preferred):
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, the base pay range for this position is $152,000 to $216,000 (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.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
