Senior Systems Engineer, R&D, Critical Care - Edwards Lifesciences
Irvine, CA
About the Job
For over 50 years, the Critical Care business within Edwards has operated at the intersection of groundbreaking medical innovation and improved patient care. Put simply, we exist because we’re committed to creating a world where every patient who should be monitored will be monitored with smart technology.
If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.
_Appendix:_
On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: http://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd
How you will make an impact:
As a Senior Systems Engineer, R&D, Critical Care, you are responsible for developing and maintaining the system Requirements and architecture for new products and is expected to collaborate with multiple disciplines that support the development of new products within our Critical Care business.
+ 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.
+ Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
+ 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.
+ Job functions require strong technical judgment, leadership, communication and coordination skills
What you'll need (Required):
+ Bachelor's degree in Engineering or Scientific field & 4+ years' experience -OR-
+ Master's degree in Engineering or Scientific field & 3+ years' experience -OR-
+ PhD degree in Engineering or Scientific field
+ Experience with writing and executing system verification and validation protocols
+ Experience with writing system-level requirements and working with different functional groups to define sub-system requirements
What else we look for (Preferred):
+ Previous electrical, software, mechanical, biomedical, or systems engineering experience working on electro-mechanical devices
+ Strong preference for experience in the medical device industry with emphasis on instrumentation/Monitors (analog and digital electronics) or medical sensors
+ Previous experience with UI/UX software development in the medical device industry
+ Previous experience working with requirement management tools such as PTC, JAMA or DOORS
+ Experience using Python or MATLAB
+ Familiarity with medical device industry standards (i.e IEC, ISO)
+ Comfortable in a dynamic working environment with a high amount of change
+ 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
+ Good leadership skills and ability to influence change
+ Ability to manage competing priorities in a fast-paced environment
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 $103,000 to $146,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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.
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.
If you're eager to contribute your expertise and commitment to Critical Care’s mission, we invite you to explore these career opportunities. Those who join us or continue their current journey within Critical Care will play their own part in improving the quality of care and outcomes for millions of patients around the world.
_Appendix:_
On June 3, 2024, Edwards announced that it had entered into a definitive agreement to sell its Critical Care product group to BD (Becton, Dickinson and Company) (NYSE: BDX). It remains business as usual at Edwards until the transaction closes. More information on Edwards’ announcement about the acquisition can be found here: http://www.edwards.com/newsroom/news/2024-06-03-edwards-lifesciences-to-sell-critical-care-to-bd
How you will make an impact:
As a Senior Systems Engineer, R&D, Critical Care, you are responsible for developing and maintaining the system Requirements and architecture for new products and is expected to collaborate with multiple disciplines that support the development of new products within our Critical Care business.
+ 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.
+ Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
+ 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.
+ Job functions require strong technical judgment, leadership, communication and coordination skills
What you'll need (Required):
+ Bachelor's degree in Engineering or Scientific field & 4+ years' experience -OR-
+ Master's degree in Engineering or Scientific field & 3+ years' experience -OR-
+ PhD degree in Engineering or Scientific field
+ Experience with writing and executing system verification and validation protocols
+ Experience with writing system-level requirements and working with different functional groups to define sub-system requirements
What else we look for (Preferred):
+ Previous electrical, software, mechanical, biomedical, or systems engineering experience working on electro-mechanical devices
+ Strong preference for experience in the medical device industry with emphasis on instrumentation/Monitors (analog and digital electronics) or medical sensors
+ Previous experience with UI/UX software development in the medical device industry
+ Previous experience working with requirement management tools such as PTC, JAMA or DOORS
+ Experience using Python or MATLAB
+ Familiarity with medical device industry standards (i.e IEC, ISO)
+ Comfortable in a dynamic working environment with a high amount of change
+ 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
+ Good leadership skills and ability to influence change
+ Ability to manage competing priorities in a fast-paced environment
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 $103,000 to $146,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career 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.
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.
Source : Edwards Lifesciences