Engineer II, R&D - Systems/Connected Solutions @ Edwards Lifesciences - Irvine, CA

The Engineer II R&D Systems – Connected Solutions is a key role in Critical Care R&D team supporting new product development in partnership with commercial teams. While system engineering at its core, this is a unique hands-on engineering position with the emphasis on medical monitoring, device connectivity through cloud based applications and usability engineering developing specifications, testing and integration. Works closely with commercial teams, Key Opinion Leaders to design and support next generation Critical Care Products.

Essential Job Responsibilities:
Write, execute Design Verification Protocols and effectively organize, capture and analyze test results
Plan, collect and translate detailed information about how users interact with Critical Care medical devices, connectivity solutions through interviews, direct observation in the field, task analysis, and simulation labs.
Support System requirements development and management related to device connectivity, usability, user experience and testing
Support Regional Marketing and Sales teams in pre-sale efforts for technical features such as connectivity, functionality, service features.
Support communication with hospital IT departments for initial deployment questions, setup, testing strategy.
Interface with sales, marketing and quality/complaint handling organization to support post-market surveillance efforts.
Drive technical root cause investigations as necessary, engaging appropriate R&D, quality and vendor resources.
Identify/create new product features and partner with Software development team to bring to fruition though clear communication by creating wireframe and storyboards
Display effective technical System Engineering skills to navigate the tasks through a large cross-functional team during the product development process.
May receive technical guidance on the most unusual or complex problems, but independently determines and develops approaches to solutions.
Will require up to 25% domestic and international travel.

Education and Experience:
Bachelor's Degree in Engineering or Scientific field & 2+ years related experience within an R&D -or- NPD capacity is required -OR-
Master's Degree or equivalent in Engineering or Scientific field & a n internship, senior project(s), or thesis r elated experience within an R&D -or- NPD capacity is required

Basic Qualifications :
Experience in various phases of R&D -or- NPD (e.g. from concepts to product launch and lifecycle management) is required

Preferred Qualifications:
Experience in the medical device or other highly regulated industry
Experience working with global teams on various time zones
Prior clinical experience in a Critical Care monitoring (hemodynamic monitoring, vital signs monitoring), Interventional, Vascular or Cardiac Surgery arena
Good understanding of design controls, such as IEC 62366, ISO 14971, 21 CFR 820
Experience with Device Connectivity and Cloud based application solutions

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 $81,000 to $114,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

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 13,000 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.

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.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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