Hybrid Systems Engineer II, R&D at Edwards Lifesciences

Many structural heart patients suffer from heart failure with limited options. Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention. Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members. 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:

As a Systems Engineer, this individual will be a member of the Research & Development team, responsible for new product design and development, risk management, and product performance improvements for the hardware components of the Cordella platform. This is a collaborative position in which the Systems Engineer will work closely with other hardware and software engineers, quality, regulatory, manufacturing, and other individuals throughout the company.

Product Development Activities:

• Verification and validation testing, including test method development, protocol writing, test execution, data analysis, and report writing

• Design change impact assessments

• Risk management activities, including Hazard Analysis, Design FMEAs, and Use FMEAs

• Standards compliance

• User research and usability assessments/validation

• Build and maintain the design history file

Troubleshooting and Problem Solving:

• Troubleshoot device problems and test failures

• Develop strategies and solutions to navigate the design and development process

Act as technical resource for field support

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 2 years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

What else we look for (Preferred):

• Prior experience performing testing to support V&V and risk management activities for medical device development

• Prior experience working within Design Controls and DHF ownership

• Prior experience processing, parsing, and analyzing data, including script development for automation and statistical analysis methods using Excel and Minitab

• Demonstrated ability to work independently with minimal supervision

• Excellent oral and written communication skills, particularly in technical writing, documentation, and presentations

• Demonstrated organizational, interpersonal, and critical thinking skills

• Experience with medical devices and FDA quality practices and standards, including ISO 13485

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including the ability to manage vendors and project stakeholders

• Ability to build productive internal/external working relationships

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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 Illinois, the base pay range for this position is $85,000 to $120,000 (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 Requirement

Edwards 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.