Edwards Lifesciences Senior R&D Systems Engineer in Irvine, California
The Senior R&D Systems Engineer will work on integrated systems consisting of mechanics, electronics, and software components. The emphasis is on medical monitoring capital equipment design, requirement development, integration work and systems verification and validation testing. The Senior R&D Systems Engineer will be working cross-functionally with R&D, Quality, Clinical affairs, Regulatory affairs, Operations and Marketing.
Provides systems engineering for complex hardware and software monitor platforms used in hospital surgical and intensive care applications.
Works directly with marketing, field sales, and clinicians to define high level system requirements, product concepts, user interfaces, patient-contact parts and disposables, and interfaces to external systems and medical devices.
Streamline development activities and define technical product development milestones
Works with electrical, software, algorithm and mechanical engineering groups to develop implementation-level engineering requirements and guide implementation direction.
Works cross-functionally with engineering, quality, and regulatory groups on product risk management, usability, human factors, and regulatory standards compliance.
Defines and executes system level verification and validation activities.
Job functions require strong technical judgment, leadership, communication and coordination skills
Education and Experience:
Bachelor's Degree in Engineering, 3+ years experience required OR
Master's Degree in Engineering, 2+ years experience required OR
Ph.D. in Engineering
1+ years of experience with MATLAB or Python
1+ years of experience with LabView and quantitative analysis of data
2+ years previous electrical, software, mechanical, biomedical, or systems engineering experience using electronic patient monitors, monitoring devices and disposable catheters / sensors
Experience in product verification & validation within an FDA regulated industry
Basic understanding of statistical techniques
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Must be a highly motivated self-starter who is able to achieve results with minimal direction. Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills. Must be proactive, organized and creative in achieving goals. Must have strong conflict resolution skills.
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Good leadership skills and ability to influence change
Comfortable in a dynamic working environment with a high amount of change
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria, as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.