Edwards Lifesciences Principal Engineer, Textiles – Cardiac Implant Network in Irvine, California
The Principal Engineer, Textiles will develop advanced textile manufacturing processes for application to implantable clinical prototypes and commercial manufacturing scale-up. In this role, the Principal Textiles Engineer 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 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 Principal Engineer will work closely with 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 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, 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.
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.
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.
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 13,000 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.