Senior Designer, Engineering

Edwards Lifesciences; Irvine (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Designer, Engineering to develop advanced medical device components within the Transcatheter Heart Valve (THV) program. You will collaborate with Quality and Manufacturing to deliver robust designs that meet stringent standards and clinical needs worldwide.

The role emphasizes complex CAD modeling, tolerance analysis, and design for manufacturing, with responsibilities spanning from concept through validation and drawing release.

Qualifications

• High School Diploma or equivalent with 10 years of related experience.
• CAD Certification or related program certification.

Responsibilities

• Creating new complex product designs utilizing parametric CAD modeling to develop basic data, complex assemblies and detailed parts of devices, mechanisms, and structures.
• Designing more complex products, incorporating ease of manufacturing, safety, performance and reliability; selecting equipment and materials and advising on revisions.
• Identifying design errors and deficiencies, recommending revisions and improvements in design layout during validation.
• Processing Engineering Change Requests (ECR) with technical justification and ensuring layout clarity and conformity to standards.
• Collaborating with Engineering to implement new processes and design products, and developing presentations for design viability.

Skills

CAD software

Tolerance analysis

Design for manufacturing

2D/3D CAD (Creo/SolidWorks)

Education

High School Diploma

CAD Certification

Tools

Creo

SolidWorks

AutoCAD

CAD PDM

Job description

At Edwards, we put patients first. We invest a significant proportion of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering team, the Senior Designer, Engineering will work closely with our Quality and Manufacturing teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients' lives around the world.

Aortic stenosis and aortic regurgitation impact millions of people globally, yet these conditions often remain under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Today, our Transcatheter Heart Valve (THV) business unit continues to pioneer next-generation innovations for patients with both aortic stenosis (AS) and aortic regurgitation (AR). We bring together Clinical Affairs, Engineering, and Research professionals who partner with cardiologists and clinical teams to design and develop minimally invasive therapies supported by clinical evidence, transforming cardiovascular care and addressing unmet patient needs in structural heart disease. It's our driving force to help patients live longer, healthier lives. Join us and be part of our inspiring journey.

How you'll make an impact:

• Creating new complex product designs utilizing parametric solid modeling software or applications to develop basic data, complex assemblies and detailed parts of devices, mechanisms, and structures, assess viability of engineering specifications/concepts including advising engineers on suggested revisions on designs.
• Designing more complex products, incorporating ease of manufacturing, safety, performance, and reliability; and selecting equipment and materials, contractual specification requirements and cost; including recommending alternates and solutions needed to achieve the intended design objective.
• Identifying design errors, omissions, and other deficiencies, and recommending revisions and/or improvements in design layout to responsible engineers or designers throughout the validation process including redline reviews.
• Process Engineering Change Requests (ECR) including describing changes and providing corresponding technical justification; checking completed layouts and drawings for clarity, completeness, conformity to standards, procedures, specifications; and accuracy of calculations and dimensioning and notes necessary to present design proposals.
• Participating in implementing new processes, methods, and design products in collaboration with Engineering.
• Developing presentations and presenting proposal on designs across internal and external functions to secure consensus on the design viability and functionality.
• Consulting with and providing input to Engineers on Edwards drawing standards and CAD tools, maintaining integrity of the CAD PDM (Product Data Management) modeling software.
• Performing more complex tolerance analysis.

What you'll need (Required):

• High School Diploma or equivalent with 10 years of related experience
• CAD Certification or related program certification

What else we look for (Preferred):

• Bachelor's degree or associate degree in engineering or a CAD/design-related field
• Proven expertise in plastic injected molded part design for both prototype and production phases. Deep understanding of molding and 3D printing strategies.
• Demonstrated hands-on experience designing plastic parts for product development, including strong understanding of injection molding principles.
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives.
• Strong leadership skills with demonstrated ability to influence change.
• Problem solving methodology, tolerance analysis, and GDP (Good Documentation Practices).
• Proven expertise in usage of CAD (e.g. Creo, SolidWorks, AutoCAD, CAD PDM) and MS Office Suite.
• Knowledge of advanced CAD strategies (e.g. Top Down Design, Master Models, Multi-Body).
• Experience reading, interpreting, and creating drawings.
• Ability to read, comprehend, write, and speak English.
• Substantial understanding of CAD design principles, techniques and procedures including parametric solid models.
• Full understanding of ASME Y14.5M-1994 drawing standards.
• Advanced ability to utilize 2-D and 3-D CAD software.
• Advanced understanding of fabrication processes (e.g. machining, molding) to leverage in creating and evaluating designs.
• Full understanding of materials and materials properties.
• Full understanding of DFM (Design for Manufacturing) concepts and principles.
• Execution of Visual Design Language (VDL) into product design. Ability to interface with internal/external Industrial Design partners.

Knowledge of