Senior Systems Engineer, R&D

Edwards Lifesciences•Irvine, CA

2d•$108,000 - $153,000•Onsite

About The Position

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. 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.

Requirements

Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field
Experience with medical devices and FDA quality practices and standards, including ISO 13485
Prior experience performing testing to support V&V and risk management activities
Prior experience working within Design Controls and DHF ownership

Nice To Haves

Experience in medical devices with both hardware and data and/or software is preferred
Experience with FDA submissions for product approvals
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.
Demonstrated organizational, interpersonal, 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 team-oriented, fast-paced, regulated environment while managing multiple priorities
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

Responsibilities

Lead development and execution of engineering project plans, including designing and conducting complex experiments (including writing and executing protocols), analyzing results, and delivering reports based on engineering principles
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
Create/update more complex design control documents including requirement specs, and risk documents (Hazard Analysis, Design FMEAs, and Use FMEAs)
Lead design change impact assessments, ensuring risks, requirements, and validations are appropriately addressed
Ensure compliance with applicable standards and regulatory requirements throughout the product lifecycle
Conduct user research and usability evaluations to support safe, effective design decisions
Maintain a complete, organized Design History File (DHF) to support traceability and audit readiness
Drive system-level strategies and solutions to effectively navigate design and development processes, ensuring alignment with technical, regulatory, and business objectives
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Evaluate input and form a technical recommendation including designing parts, components and subsystems
Train, coach, and guide lower-level employees on routine procedures
Other duties assigned