Senior Distinguished Engineer, R&D

Edwards Lifesciences • Irvine, CA

1d • $191,000 - $271,000

About The Position

Innovation starts from the heart. 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, you’ll develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. The Senior Distinguished R&D Engineer position within the Transcatheter Mitral and Tricuspid Therapies (TMTT) division at Edwards Lifesciences offers a unique opportunity to contribute to early innovations while supporting the major therapies within the business unit. The successful candidate will play a critical role in leading the development of an early stage, highly novel catheter delivery system and provide on an as needed basis, support to the established therapies in next generation product development. This position is ideal for someone who thrives in a fast-paced, small team environment and who is self-sufficient and can manage product development tasks with minimal supervision. How you’ll make an impact: Provide strategic direction and guidance, and play a pivotal role in complex problem solving on R&D projects owning multiple complex material and/or design workstreams (e.g., system level design ownership) Advise/develop clinically relevant test methods to specify materials/components Design from concept to FIH (first in human) or efficiently evaluate critical technology strategy and roadmap. Create need based technologies from concept to FIH or instrumental in evaluation and selection of new strategic technologies Conceptualize, design, and develop complex interventional catheter delivery systems intended for the delivery of implantable devices, including establishing design requirements, generating concepts, and building prototypes. Influence technology roadmap for system level, multiple components in new therapy including identifying investment areas Participate in external forum of professional societies, regulatory agencies, and academic liaison to influence policies, standards, and regulatory guidance in critical fields of technology Guide and mentor engineers on new and emerging technologies and projects, and actively engage in knowledge sharing and technology symposium(s) Develop and execute test methods and procedures to assess device prototype performance. Analyze and interpret data to drive design decisions and to assess design risk. Present design concepts and test findings to peers and management to drive project decisions Collaborate closely with clinical, engineering, and physician partners in early-stage development, leveraging strong knowledge of cardiovascular anatomy, heart structure, and valve diseases. Serve as a critical role in identifying new platforms for advancing EW in future business needs Drive, evaluate, and influence innovative solutions that support technical strategies

Requirements

• Bachelor's Degree in Engineering or Scientific field plus15 years of related experience -or- Master's Degree or equivalent in Engineering or Scientific field plus 14 years of related experience -or- Ph.D. or equivalent in Engineering or Scientific field plus 11 years of related experience

Nice To Haves

• Extensive experience in complex catheter shaft and/or handle design
• Expertise in mechanical design
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Experience with catheter manufacturing processes such as extrusions, braiding, molding, reflow and bonding.
• Ability to effectively communicate with collaborating partners (strategy, marketing, physicians)
• Demonstrated ability to apply technical knowledge and judgement to complex engineering problems.
• Strong innovation and problem-solving skills, along with mentoring abilities for junior engineers.
• Experience in rapid product development and prototyping.
• Ability to quickly iterate and respond to feedback from stakeholders.
• Preferred background includes experience in interventional cardiovascular catheter-based devices
• Self-starting, energetic, and able to achieve results with minimal direction.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Responsibilities

• Provide strategic direction and guidance, and play a pivotal role in complex problem solving on R&D projects owning multiple complex material and/or design workstreams (e.g., system level design ownership)
• Advise/develop clinically relevant test methods to specify materials/components
• Design from concept to FIH (first in human) or efficiently evaluate critical technology strategy and roadmap.
• Create need based technologies from concept to FIH or instrumental in evaluation and selection of new strategic technologies
• Conceptualize, design, and develop complex interventional catheter delivery systems intended for the delivery of implantable devices, including establishing design requirements, generating concepts, and building prototypes.
• Influence technology roadmap for system level, multiple components in new therapy including identifying investment areas
• Participate in external forum of professional societies, regulatory agencies, and academic liaison to influence policies, standards, and regulatory guidance in critical fields of technology
• Guide and mentor engineers on new and emerging technologies and projects, and actively engage in knowledge sharing and technology symposium(s)
• Develop and execute test methods and procedures to assess device prototype performance.
• Analyze and interpret data to drive design decisions and to assess design risk.
• Present design concepts and test findings to peers and management to drive project decisions
• Collaborate closely with clinical, engineering, and physician partners in early-stage development, leveraging strong knowledge of cardiovascular anatomy, heart structure, and valve diseases.
• Serve as a critical role in identifying new platforms for advancing EW in future business needs
• Drive, evaluate, and influence innovative solutions that support technical strategies

Benefits

• Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree