Systems Engineer II, R&D, Critical Care - Edwards Lifesciences
Irvine, CA
About the Job
For over 50 years, the Critical Care business within Edwards Lifesciences (NYSE: EW) 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.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
_Appendix_ : For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99: https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx
As a Systems Engineer II , this individual is responsible for evaluating system requirements and has direct ownership of system integration, verification, and validation for new and existing products within our Critical Care Business.
How you will make an impact:
+ Provides systems engineering testing for complex hardware and software, GUI interfaces, algorithms, monitor platforms used in clinical environments
+ Defines and executes system level verification and validation activities
+ Work with downstream functional engineering groups to integrate software, algorithms, electronics, and mechanical features into the product.
+ Partners with upstream cross functions to define clinical workflows and user interaction use-cases.
+ 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 in Scientific field (e.g. Engineering, Computer Science, etc.), with a minimum of 2 years of experience -OR-
+ Master's Degree or equivalent in with an internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
+ Statistical experience is required (i.e. MATLAB, Minitab)
+ Experience or coursework in both software and basic electronics
What else we look for (Preferred):
+ Strong preference for experience with medical instrumentation/monitors (analog and digital electronics) or medical sensors
+ Experience with writing and executing system verification and validation protocols
+ Experience with reviewing system-level requirements and working with different functional groups to define sub-system requirements
+ Experience with design of experiments (DOE)
+ Direct experience in systems V&V related activities within the medical device industry is desired (complex electro-mechanical device experience strongly preferred)
+ Familiarity with medical device industry standards (i.e. IEC, ISO) is desired
+ Experience developing test tools & test methods for systems verification
+ Previous experience working with requirement management tools such as PTC, JAMA or DOORS
+ Experience using Python or MATLAB
+ 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
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 $83,000 to $117,000 (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 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers 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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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.
With this impactful vision in mind, we are now embarking on becoming an independent business from Edwards, a process that we currently expect to be completed by January 2025.
As Critical Care transitions to an independent company, we will continue to benefit from the expertise and experience of 4,000+ dedicated global employees, a vibrant innovation engine with strong investment in our future pipeline, and strong sales growth and profitability. We are well-positioned to build upon our category leadership as we continue to launch new solutions powered by A.I. to clinicians, and expand into new care settings.
So, if you're a dynamic and passionate person who is eager to contribute to an innovative, industry-leading advanced monitoring company we invite you to explore our career opportunities. Those who choose to join us will be part of a ‘once-in-a-lifetime’ journey to improve the quality of care and outcomes for millions of patients around the world.
_Appendix_ : For further detail on the spin-off of Critical Care from Edwards Lifesciences, please consult this 2023 Investor Conference Presentation, pages 89-99: https://ir.edwards.com/events-presentations/event-details/2023/Edwards-Lifesciences-2023-Investor-Conference-2023-bK2BbXaBha/default.aspx
As a Systems Engineer II , this individual is responsible for evaluating system requirements and has direct ownership of system integration, verification, and validation for new and existing products within our Critical Care Business.
How you will make an impact:
+ Provides systems engineering testing for complex hardware and software, GUI interfaces, algorithms, monitor platforms used in clinical environments
+ Defines and executes system level verification and validation activities
+ Work with downstream functional engineering groups to integrate software, algorithms, electronics, and mechanical features into the product.
+ Partners with upstream cross functions to define clinical workflows and user interaction use-cases.
+ 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 in Scientific field (e.g. Engineering, Computer Science, etc.), with a minimum of 2 years of experience -OR-
+ Master's Degree or equivalent in with an internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education
+ Statistical experience is required (i.e. MATLAB, Minitab)
+ Experience or coursework in both software and basic electronics
What else we look for (Preferred):
+ Strong preference for experience with medical instrumentation/monitors (analog and digital electronics) or medical sensors
+ Experience with writing and executing system verification and validation protocols
+ Experience with reviewing system-level requirements and working with different functional groups to define sub-system requirements
+ Experience with design of experiments (DOE)
+ Direct experience in systems V&V related activities within the medical device industry is desired (complex electro-mechanical device experience strongly preferred)
+ Familiarity with medical device industry standards (i.e. IEC, ISO) is desired
+ Experience developing test tools & test methods for systems verification
+ Previous experience working with requirement management tools such as PTC, JAMA or DOORS
+ Experience using Python or MATLAB
+ 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
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 $83,000 to $117,000 (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 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 Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers 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, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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