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Senior Engineer

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: May 25, 2023

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience.Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. -For more than 50 years, we have established a remarkable track record around that innovation: Work that enables clinicians around the world to enhance and save lives.The THV Pulmonic NPD team is looking for a Senior Engineer to support the expansion of the Alterra Pre-Stent Delivery System and the Pulmonic Valve Delivery System product lines. This Sr. Engineer will have the opportunity to drive process design and characterization, work on a strong cross-functional team, and partner with the commercial site on process validations and commercialization activities. Through the current devices and active line extensions this position provides experience in the full development cycle from concept through to commercialization.Key Responsibilities:

  • Drive process development and characterization for Clinical and Commercial device releases using DMAIC methodologies
  • Create user requirement specifications for process equipment
  • Collaborate on tooling and fixture design
  • Develop process validation strategies and participate in validation execution in conjunction with the commercial manufacturing site
  • Drive process DFM, process FMEAs, and mistake proofing analysis and implementation
  • Collaborate on test method development
  • Participate in product design and specification development
  • Participate in product risk analysis
  • Partner with Operations and Supply Chain at the Pilot or Commercial manufacturing site for successful Clinical and Commercial device releasesMinimum Qualifications:
    • Bachelor's Degree in Engineering or Scientific field with 4 years of industry experience OR Master's Degree in Engineering or Scientific field with 3 years of industry experience requiredPreferred Qualifications
      • Strong verbal/written communication and interpersonal skills
      • Basic understanding of statistical techniques required; Six Sigma Black Belt Certification preferred
      • Previous experience in a manufacturing support role preferred
      • Strong problem-solving, organizational, analytical and critical thinking skills
      • Process Validation experience strongly preferred
      • Familiarity with Design for Manufacturability and LEAN is preferred
      • Capable of analyzing and solving complex problems through innovative thought and experience
      • Ability to manage competing priorities in a fast-paced environment
      • Ability to work well independently as well as part of a team
      • Good leadership skills and ability to influence change
      • Ability to interact professionally with all organizational levelsAligning 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 $101,000 to $142,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. 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.About Us 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.

Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Engineer, Engineering , Irvine, California

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