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Edwards Lifesciences Staff Engineer, R&D - Transcatheter Heart Valve in Irvine, California

Join a premier engineering team working at the forefront of new and innovative technologies which directly save lives.

Edwards Lifesciences is currently seeking a high caliber Product Development Engineer who will be a key player to develop and design novel medical devices for our Transcatheter Heart Valve Business Unit at our corporate headquarters in Irvine, CA.

The StaffEngineer applies knowledge of technical principles, related to polymer-based materials and corresponding manufacturing techniques not limited to textiles to develop new and/or to optimize current soft components following Edwards’s systems and procedures

Responsibilities:

  • Collaboratewith team to create/develop internal technical capabilities and expertiserelated to polymeric raw materials, polymers, finishing processes suchthermo-shaping and substrate coating and related technologies

  • Conceptualize, design and develop complex, components,tooling, equipment, and processes for class III implantable devices. Thisincludes hands-on-work on rapidprototyping, design and development of equipment and processes formanufacturing of polymer-based components, project team support, andinterfacing with key external suppliers.

  • Work closely with project team members and internalpartners to deliver project's technical objectives.

  • Assist design selection based on clinical impact,material, and supplier manufacturability. Assist development of testmethods and procedures to evaluate prototype performance.

  • Activelyparticipate in new-product development and technology efforts related tosoft components

  • Developdesign and process specifications to meet user needs

  • Performtooling/fixture, equipment and process qualifications (TFIQ/IQ/OQ/PQ).

  • Driveincorporation of technical advancements into manufacturing process andtechnology employed in the manufacture of both existing and new products

  • Developsolutions to manage complex manufacturing process design, development andvalidation efforts from early product development through product launchas needed

  • Performmaterial characterization using suitable physical and chemical methods andtesting per ASTM, ISO, ASTM standards

  • Identify,evaluate and provide guidance to suppliers, including tolerances andacceptance criteria related to design and manufacturing processes

  • Continuallyimprove existing processes, manufacturability and sustainability

  • 10-20%Possible travel (Domestic and/or international)

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Qualifications:

Qualifications:

Bachelor’s degree in engineering discipline such as biomedical engineering, materials science, Textiles Science/ Engineering or equivalent/allied discipline preferably with a Polymer Science and fibers background is required

Must have 6 years of experience in an industrial environment as a technical leader

Required Skills:

  • An understanding of polymer physics, materialcharacterization, structure-property relations and utilization towardsapplication development

  • Experience in the development of syntheticpolymeric components, textile-based products and processes is ideal

  • Hands-on experience with designing and fabrication oftools/fixtures

  • Experience in medical devices product/processdevelopment

  • Knowledge of medical devices regulations andexperience incorporating manufacturability into the new productdevelopment is desired

  • Experience with rapid product development incross-functional teams, creative design, prototyping, and test methoddevelopment.

  • Ability to work in a team-oriented environmentthat embraces change, risk management, and flexibility

  • Ability to handle multiple projects/tasks atthe same time

  • Demonstrated ability to work independentlywithin a team with sense of urgency against timelines

  • Demonstrated ability to listen to customers'needs, develop solutions to meet their requirements,

  • Strong mechanical aptitude, including hands-onskills with proven ability to apply technical knowledge and judgment tocomplex technical problems

  • Highly effective verbal and writtencommunication skills

  • Demonstrated project ownership andaccountability for project results

  • Knowledge of Design/Process Excellence (SixSigma) with good understanding ofstatistical techniques for developing processes, such as Design ofExperiments (DOE), range finding, and process capability studies is plus.

About Edwards

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. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Title: Staff Engineer, R&D - Transcatheter Heart Valve Location: USA-USA-California - Irvine Job Number: 021535

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