Systems Engineer II,R&D Job Irvine area,California USA,Engineering

Systems Engineer

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.

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.

This is an on-site role based at our corporate headquarters in Irvine, CA. The selected candidate must reside in the local region.

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.

Support development and execution of engineering project plans, including designing and conducting experiments, analyzing results and preparing technical reports

Create work instructions, test methods, models, and prototypes to characterize and support product and process specifications

Develop and update design control documentation (e.g. requirements, hazard analyses, DFMEAs, UFMEAs) under guidance

Perform design change impact assessments evaluating effects on risk, requirements, and verification/validation activities

Ensure adherence to applicable standards, regulatory requirements, and internal procedures throughout development

Conduct user research and usability evaluations to inform safe and effective design improvements

Contribute to maintaining the Design History File (DHF), ensuring documentation is complete, accurate, and traceable

Support system-level problem-solving and contribute to design and development strategies aligned with project objectives

Coordinate and provide guidance to technicians on test execution and routine R&D support activities

Evaluate technical inputs and contribute to design recommendations for components and subsystems

Perform additional duties as assigned

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
Experience with medical devices and FDA quality practices and standards, including ISO 13485
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
Strong written and verbal communication skills with the ability to clearly document technical rationale and present findings to cross-functional stakeholders.
Solid problem-solving, organizational, analytical and critical thinking skills
Strict attention to detail and commitment to high quality documentation
Ability to interact professionally with all organizational levels
Ability to work effectively in a fast-paced, regulated environment while managing multiple priorities.
Must be able to work in…

Systems Engineer II, R&D