Senior Principal Engineer, Textiles - Cardiac Implant Network

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

Job Description:

The Sr. Principal Engineer, Textiles will develop advanced textile manufacturing processes for application to implantable clinical prototypes and commercial manufacturing scale-up. - In this role, the Sr. Principal Textiles Engineer, in partnership with the Textile Center of Excellence (CoE), will design, develop and prototype knit, woven and braided textile component structures using synthetic fibers and yarns to meet the engineering, manufacturing and commercial requirements of the Cardiac Implant Network. - This role will work closely with our CoE, textile suppliers, technology partners, consultants, and academia to deliver engineered polymer fibers and textile components to our medical devices from concept through product launch. - This individual will also identify opportunities and lead cross functional teams to improve manufacturing process technology using LEAN & SIX Sigma methods and will lead root cause analyses to resolve complex manufacturing and compliance issues.As a textiles subject matter expert, the Sr. Principal Engineer will work closely with CoE, Quality, Research & Development, New Product Development and Sustaining Engineering functions to identify, select, design, develop & qualify fibers, textile structures, manufacturing processes and textile components while mitigating technical and business risks. - This role will represent the Cardiac Implant Network to suppliers and technological partners and will manage strategic relationships in the industry.The Sr. Principal Textiles Engineer will employ project management techniques to measure progress and manage risk associated with programs and projects and work with internal & external stakeholders to develop and execute appropriate mitigation plans. - This role will be accountable to attain technical and business objectives and periodically report results to the Senior Leadership Team.Essential job functions include:

• Plan and lead complex development and Early Human Use (EHU) prototyping of textile materials and components.
• Work with internal stakeholders to assess materials, technologies and suppliers for selection, approval and component qualification.
• Identify and capture opportunities to improve manufacturing processes using Design for Manufacturability, Six Sigma and Lean Manufacturing principles.
• Manage key supplier and technological partner relationships.
• Work in a high energy, cross functional team environment which includes R&D, CoE, Regulatory, Quality, Manufacturing, and Supply Chain to ensure project objectives are met.
• Perform root cause and corrective action investigation of complex materials and processes non-conformances.
• Conduct periodic schedule, performance & risk reviews with stakeholders, suppliers and internal Senior Leadership teams.
• Travel up to 25%.
• Perform other duties and responsibilities as assigned.Qualifications:
  • Bachelor's Degree or equivalent in Textiles Engineering with a strong background in polymer science and eight years industry experience, or
  • Master's Degree in Textiles Engineering with a strong background in polymer science and seven years industry experience.Preferred Qualifications:
    • Doctorate in Textiles Engineering with a strong background in polymer science and four years industry experience.
    • Medical device industry experience strongly preferred.
    • Demonstrated expertise in Textiles engineering, polymer science and textiles manufacturing technology.
    • Advanced problem-solving, organizational, analytical and critical thinking skills.
    • Strong technical leadership and project management skill with demonstrated ability to influence stakeholders and senior leadership team members.
    • Demonstrated ability to establish and maintain working relationships with strategic raw material and component suppliers, academia and other technological partners.
    • Ability to manage complex technical projects and actively manage risk under heavy schedule constraints.
    • Create, review and analyze process Failure Modes & Effects Analysis.
    • Develop, conduct & interpret Design of Experiments (DOE) studies.
    • Develop, conduct and analyze process capability studies.
    • Able to manage priorities with a strong sense of urgency in a fast-paced environment.
    • Experience in the use of Six Sigma & Lean Manufacturing principles. - Six Sigma Black Belt desirable.
    • Identifying and driving innovative process and equipment projects for improved safety, cost, quality, capability, and capacity.
    • Mastery of fundamental statistics and statistical principles.
    • Knowledge of applicable compliance regulations for the medical device industry & experience working in a highly regulated environment.
    • Experience in the training, direction and mentorship of technical personnel.
    • Ability to interact professionally with all organizational levels.
    • Proficient in MS Office Suite, including MS Project.
    • CAD, MiniTab and MatLab experience is highly desirable.
    • Strong verbal/written communication and interpersonal skills including conflict and relationship management.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 Principal Engineer, Textiles - Cardiac Implant Network, Engineering , Irvine, California