Senior Principal Engineer, Textiles - Cardiac Implant Network
Company: Edwards Lifesciences Gruppe
Posted on: January 25, 2023
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
- 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
- Identify and capture opportunities to improve manufacturing
processes using Design for Manufacturability, Six Sigma and Lean
- Manage key supplier and technological partner
- 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
- Bachelor's Degree or equivalent in Textiles Engineering with a
strong background in polymer science and eight years industry
- Master's Degree in Textiles Engineering with a strong
background in polymer science and seven years industry
- 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
- Develop, conduct & interpret Design of Experiments (DOE)
- Develop, conduct and analyze process capability studies.
- Able to manage priorities with a strong sense of urgency in a
- 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
- Mastery of fundamental statistics and statistical
- Knowledge of applicable compliance regulations for the medical
device industry & experience working in a highly regulated
- Experience in the training, direction and mentorship of
- Ability to interact professionally with all organizational
- 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
Keywords: Edwards Lifesciences Gruppe, Irvine , Senior Principal Engineer, Textiles - Cardiac Implant Network, Engineering , Irvine, California
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