Edwards Lifesciences Principal Engineer, R&D Supplier Development – TMTT in Irvine, California
A unique opportunity for the right creative and technical professional. The principal engineer will work within suppliers and cross functional teams on the development of Transcatheter Mitral Tricuspid Therapies (TMTT), and in the composition of components and catheters to bring products from concept to launch. This engineer will serve in a technical leadership role and collaborate closely with key internal and external stakeholders to ensure the design meets user needs, including but not limited to device ease of use, manufacturability, cost effectiveness, and operations efficiency. In addition to technical responsibilities, this engineer will use strong project management skills and a deep knowledge of Design Control and Catalyst processes to ensure effective project implementation.
Lead efforts on the cross functional team to generate, review, and approve drawings and design control documentation.
Responsible for new plastic and/or metal extruded, injection molded, or machined components providing end-to-end qualification, from design input through validation. This includes part design, process development on new tools, material change and process improvements.
Apply sound engineering principles and practices to the design and testing of medical devices.
Support suppliers and internal test plans, protocols, and reports. Analyze and present results, applying statistical analysis as necessary.
Work with and provide oversight to suppliers on the design and procurement of components, tooling and fixtures for the design, testing, inspection or assembly of products.
Generate prototypes, evaluate and make recommendations on concepts and design modifications based on key stakeholder feedback.
Interface with R&D, operations, marketing, regulatory and supply chain stakeholders to design for manufacturability and cost improvement strategies.
Support design control review meetings to ensure completion of required project deliverables, and coordinate follow up activities with cross functional team members on action items.
Lead or facilitate technical update meetings and reviews with R&D, operations, marketing and regulatory.
Perform other duties and responsibilities as assigned.
Qualified applicant must possess the following criteria: Qualifications
B.S. degree in Mechanical Engineering, Biomedical Engineering, or related engineering degree.
Minimum of ten years of experience in medical device mechanical design.
Experience in catheter design and manufacturability with a variety of materials including plastics and alloys.
In-depth knowledge of Design Control requirements and experience generating documentation including Part Qualification Plan, Design Requirements, Risk Management, Design Verification and Validation.
Experience in the use of statistical tools required (SPC, Six Sigma, DMAIC, etc.).
On-site work required.
25% travel required.
Master’s degree in Mechanical Engineering, Biomedical Engineering, Polymer/Plastics Engineering or related discipline.
Black Belt certification preferred.
Experience in one or more of the following: Catheter technology in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices.
Experience in CAPA elements and implementation.
Technical team leadership capability with strong self-motivation, project management skills, and demonstrated ability to lead a cross functional team while optimizing resources to deliver project results. Possess a successful track record of medical device product development from concept through launch.
Ability to work on complex problems and projects where analysis of situation or data requires an in-depth, solid understanding of engineering principles. Use creative ability to design and problem solve.
Strong analytical skills and ability to translate key input from multiple internal and external stakeholders.
Effective verbal/written communication and interpersonal skills including conflict and relationship management.
Understanding of Statistical Techniques is required. Experience with statistical analysis software (Minitab), Geometric Dimensioning and Tolerancing (ASME Y14.5-2009), Stack Up Analysis, DOE, Gage R&R preferred.
CAD experience using SolidWorks preferred.
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 15,000 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.