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

    Edwards Lifesciences Gruppe
    Edwards Lifesciences Gruppe Irvine, United States

    1 week ago

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    Senior Engineer, R&D Supplier Development

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    locations

    USA - California – Irvine

    time type

    Full time

    posted on

    Posted Yesterday

    job requisition id

    Req-32232


    Job Description:
    The Sr.

    Engineer, R&D Supplier Development will reside in the Transcatheter Mitral and Tricuspid Therapies (TMTT) Supplier Development Engineering team to provide manufacturing engineering support in the design and development of implantable devices and delivery systems to treat cardiovascular disease.

    Conduct engineering activities from initial product development phase through product launch. Develop manufacturing technologies to meet new product demands. Apply Design for Manufacturability (DFM) concepts, tools and analysis. Conduct reviews to ensure DFM considerations are incorporated into designs. Assess and develop supplier part capability. Work directly with suppliers to address specifications and quality requirements. Lead supplier validation activities, support initial builds and commercialization of new product introduction. Integrate new products into manufacturing. Manage product phase in/phase out activities around design, regulatory and clinical requirements. Support manufacturing readiness reviews and manage design transfers to manufacturing.


    You'll make an impact by:


    Provide technical input for strategic sourcing projects, including evaluation of supplier capability, part qualification plan, specification review, product implementation and part transition to manufacturing.

    Participate in technical discussions with suppliers to identify and implement improvements in products and processes.
    Perform design and drawing reviews to ensure that components meet desired capabilities for manufacturing.

    Responsible for defining supplier qualification requirements for OEM, Contract manufacturer (components and devices) and custom materials, including supplier validations and Edwards receiving inspection fixture design for Test method validation.

    Respond with a high sense of urgency to quality issues and escalate / communicate appropriately.
    Ensure that Tier 1 suppliers are using capable Tier 2 suppliers and resolve any inter-company conflict effectively.
    Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner.
    Work with suppliers to optimize processes, reduce cost, ensure lean manufacturing as well as remove any waste from processes.
    Develop and manage project milestones in line with development and commercialization needs.
    Perform supplier risk & capacity assessment and take appropriate actions to ensure timely and successful commercialization.
    Audit suppliers for their technical capabilities as well as quality criteria.
    Perform other duties and responsibilities as assigned.

    What you'll need:
    Bachelor's Degree or equivalent in Engineering or Scientific field with, 4 years' experience including either industry or industry/education.
    Experience in the use of statistical tools (SPC, Six Sigma, DMAIC, etc.).
    On-site work required
    Up to 15%

    domestic/international

    travel

    What else we look for:
    Master's Degree or equivalent in Engineering or Scientific field with, 3 years' experience including either industry or industry/education
    Experience in catheter manufacturing technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
    CAD experience using ProE/Solidworks
    Strong analytical, problem solving and technical writing skills.
    Strong Project management skills.
    Ability to work well both independently and as a member of a team.
    Effective verbal/written communication and interpersonal skills including conflict and relationship management.

    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.
    E dwards 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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