Edwards Lifesciences Staff Sustaining Engineer, R&D - Critical Care in Irvine, California
This is an excellent opportunity to join a newly-created engineering team within the Critical Care R&D organization working on industry-leading patient sensors and diagnostic devices. Edwards is the global leader in patient-focused innovations for critical care monitoring and is actively expanding its portfolio to transform care for the many patients we serve. The R&D sustaining engineering team is looking for a candidate with the right set of innovative technical and problem solving skills to contribute to the development and continuous improvement of Critical Care patient monitoring platforms.
Key responsibilities include:
Drive ideation, design, hands-on prototyping, and feasibility testing of design enhancements for newly-introduced electro-mechanical patient monitoring platforms.
Identify product design opportunities and manufacturing process improvements.
Collaborate with cross-functional teams to investigate manufacturing and field issues; Design, test, and implement corrections.
Generate test protocols, reports, and supporting documentation for formal design verification.
Collaborate with suppliers on design improvements, cost and scrap reduction, and manufacturing process upgrades.
Support new product development teams.
Mentor junior-level technical staff.
An effective candidate must have hands-on skills with the proven ability to independently apply deep technical knowledge, perform detailed design analyses, and apply sound judgement to lead complex initiatives. Creative mechanical development skills are required.
Demonstrated innovation, curiosity and ability to tackle technical problems.
Demonstrated track record of delivering on projects in a high energy environment.
Strong mechanical aptitude.
Knowledge of design and manufacturing of electro-mechanical medical devices.
Experience with patient sensors a strong plus.
Proven design skills using 3D CAD solid modeling software.
Experience with 3D CAD data management systems.
Proficient ability to use finite element tools for design analysis (i.e structural, thermal, mold flow, etc).
Deep materials knowledge desired.
Solid understanding of general manufacturing processes including machining, injection molding, thermoforming, extrusions, additive manufacturing, and surface treatments.
Experience with DFM methodologies and a passion for delivering highly-manufacturable products.
Expert understanding of the ASME Y14.5M-2009 drawing standards.
Must be a highly motivated self-starter able to achieve results with minimal direction.
Highly effective verbal and written communication skills are necessary (This position requires extensive collaboration, working cross-functionally, and presentations to executive staff).
A bachelor’s degree in mechanical engineering and a minimum of 6 years of relevant engineering experience are required.
Strong knowledge of design and development of electro-mechanical medical devices.
Knowledge of injection molding, sheet metal, machining, and thermoforming design methodologies for reusable and disposable parts.
Knowledge of general manufacturing processes including injection molding, sheet metal, machining, and various plastic part joining technologies.
Knowledge of Medical Electrical Safety Standard.
Strong knowledge of SolidWorks or Creo CAD solid modeling software.
Hands-on experience with finite element analysis (FEA) tools (i.e. Abaqus or Ansys).
Understanding of the ASME Y14.5M-2009 drawing standards.
Strong problem-solving, organizational, analytical, and critical thinking skills.
Capability to quickly learn and interpret complex systems is required.
Ability to effectively communicate and collaborate with the team is essential.
Effective organizational and prioritization skills are critical for success in this position.
Strong written and verbal communication, interpersonal, and relationship building skills.
Ability to plan, organize, and manage time effectively.
Ability to work both independently and as a team member with minimal direction.
Edwards has been advancing the care of the acutely ill for more than 40 years. Starting with the development of Swan-Ganz advanced hemodynamic monitoring devices for measuring cardiovascular performance in high-risk surgical and critically ill patients, Edwards continues to evolve to less-invasive and noninvasive devices to provide valuable hemodynamic insight for an expanded patient population. Edwards has continued to advance hemodynamic monitoring platforms to enable proactive clinical decisions for surgical, anesthesia and critical care clinicians. Edwards is focused on helping clinicians enhance knowledge and standardize practice to improve the quality and efficiency of care. Edwards provides evidence-based programs such as Enhanced Surgical Recovery Program that support the implementation and compliance to protocolized care pathways in the OR and ICU.
Our vascular therapies products, including genuine Fogarty catheters, continue this high standard. Developed and refined in close collaboration with surgeons and interventionalists for over 50 years, Fogarty catheters have been used in millions of procedures worldwide.
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 10,000 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. Edwards is an Equal Opportunity/Affirmative Action employer including Minorities, Females, Protected Veterans, and Individuals with Disabilities.
Title: Staff Sustaining Engineer, R&D - Critical Care Location: USA-USA-California - Irvine Job Number: 013323