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    Senior Engineer, R&D - Irvine, United States - Edwards Lifesciences

    Edwards Lifesciences
    Edwards Lifesciences Irvine, United States

    1 week ago

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    Description

    Innovation starts from the heart. Our Advanced Technology (AT) teams harness the imagination, courage, and resourcefulness to think beyond what's currently possible, and create solutions for patients many years into the future. If you're an early-stage innovator, then Edwards AT team is the place for you to take the next steps in your career. We'll give you the tools and resources you need to create groundbreaking innovations that shape the future of structural heart technology.

    Your ideas and expertise can change a patient's life As an Edwards Lifesciences' Advanced Technology R&D Catheter Team member, you will employ your talents and passions to innovate novel therapies to combat the overwhelming structural heart failure epidemic. You will join a dedicated team of engineers focused on generating novel delivery catheters and accessories. The Senior Engineer, R&D will play a pivotal role in the design, development and testing of catheters and sheaths from concept to early clinical feasibility and commercialization.

    How you will make an impact:

    • Utilize knowledge in catheter design to advance innovation and develop solutions that satisfy project and R&D requirements.
    • Interface with other engineers in various cross-functional teams to gather input to develop catheter devices.
    • Execute new products through product development cycles such as design verification, design validation, biocompatibility testing, etc.
    • Collaborating with clinical engineering and physician training partners who deeply understand cardiovascular anatomy and structural heart therapy in pre-clinical and clinical environments.
    • Interface with cross-functional teams (Manufacturing, Quality, and Regulatory) to ensure compliance with internal and regulatory policies and standards.
    • Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
    • Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity in designing and testing parts, components, and subsystems.
    • Support project teams by providing engineering knowledge and expertise to the design and development of new products.
    • Help drive Design for Manufacturing (DFM) within early development R&D projects
    • Support the design, optimization, testing, and manufacturing of catheter devices. This includes design requirement development, generating design concepts and prototypes, experimental testing, data analysis, and conducting pre-clinical evaluations.
    • Develop and manage work plans and timelines within the scope of assigned projects.
    • Support supplier development activities
    • Create component drawings and models that comply with Quality System Standards
    • Support clinical development and possibly clinical field activity
    What you'll need:
    • Bachelor's degree in engineering or Scientific field, 3 years' experience required or Master's Degree or equivalent in Engineering or Scientific field, 2 years' experience required or Ph.D. or equivalent in Engineering or Scientific field, 1 year experience
    • Experience with catheter, sheath and/or accessories design and manufacturing
    • Experience with Product Development Cycles
    • Familiarity with human heart anatomy and physiology and the types, symptoms, causes, and treatments of structural heart disease.
    What else we look for:
    • Familiarity and experience with catheter building (braiding, extrusion, balloons, molding, etc)
    • Proficiency in the usage of relevant R&D computer software (CAD, solidworks)
    • Proficiency in lab equipment and test methods such as Instron/tensile testing, simulated clinical use, etc.
    • Clinical aptitude is strongly preferred
    • Excellent documentation and technical presentation/communication skills
    • Excellent interpersonal relationship skills including negotiating and relationship management skills
    • Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
    • Advanced problem-solving, organizational, analytical and critical thinking skills
    • Extensive understanding of processes and equipment used in assigned work
    • Ability to manage competing priorities in a fast paced environment
    • Identify and implement practical solutions based on device requirements and project timelines.
    • Adaptable and capable of working in dynamic and ambiguous environments.
    • Desire and willingness to remain in a individual contributor technical role for at least 3 years.
    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 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.
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