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Senior Design Assurance Engineer

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: March 19, 2023

Job Description:

The Sr Design Assurance Engineer (QE) will provide support for transcatheter mitral and tricuspid (TMTT) development projects focusing on risk management, test method development, inspection methodologies, and design transfer. - This includes close coordination with manufacturing sites for test or clinical builds as well as lab activities for design verification testing with R&D. The QE will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.Key Role Responsibilities:

  • Focus on activities supporting design control, design verification/validation, FMEA/risk management, specification development, statistical reliability, critical to quality/process control, acceptance sampling, and inspection/test methodologies
  • Partner with R&D in the design of safe and effective devices, partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality support for pilot production of test or clinical devices.
  • Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Partner with R&D on the development of methods for design verification testing. Manage the test method validation for design verification testing including protocol/report writing, identification and procurement of test samples and execution of testing.
  • Other incidental duties assigned by LeadershipEducation and Experience Requirements:
    • Bachelor's Degree in Engineering or related field, plus minimum 4 years relative quality engineer experience required
    • Master's Degree in Engineering or related field will offset 1 (one) year required experience.
    • Experience in Design Assurance and Design Verification required
    • Experience as a Quality Engineer in Medical Device or Biotechnology industry required.
    • Some Supplier Quality experience a plus (not required)Additional Skills and Experiences:
      • Demonstrated understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering and Design Assurance
      • Professional knowledge of and adherence to Quality systems
      • Proficient level utilization of MS Office Suite (Outlook, Word, Excel, MS Project); CAD experience preferred
      • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
      • Working knowledge and understanding of statistical techniques
      • Strong problem-solving, organizational, analytical and critical thinking skills
      • Ability to manage competing priorities in a fast paced environment
      • Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
      • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
      • Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlAligning 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).Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.

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

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