Principal Engineer, R&D

This is an exclusive Irvine-based opportunity for a passionate, patient-focused Principal R&D Engineer who is motivated to join a development team that provides solutions to patients suffering from tricuspid valve disease. The Transcatheter Mitral and Tricuspid Therapies (TMTT) division is dedicated to solving the complex challenges of mitral and tricuspid disease to transform treatment and significantly improve patients’ lives. This unique position focuses on the design, development, testing, and implementation of a high visibility, next generation accessories program and transcatheter tricuspid valve replacement delivery system, carrying it from early design to commercialization. This position will report into the R&D Director of Transcatheter Tricuspid Delivery Systems.

The time is now to join TMTT and shape mitral and tricuspid therapies that will transform treatment. Don’t miss your chance to be part of a dynamic, challenging, and rewarding environment that offers potential for growth and professional advancement for the right candidate.

Key Responsibilities:

• Provide R&D engineering leadership to drive the development activities to launch associated accessories with the next gen novel delivery system
• Lead in the improvement, design and optimization of more complex experiments, tests, analyze results, provide complex recommendations, and develop reports, based on engineering principles that translate to innovative products
• Oversee R&D support tasks; give instruction to technicians/engineers on conducting tests; train technicians/engineers and provide feedback; and coordinate technician/engineer work.
• Proactively identify issues, achieve resolution, and resolve problems of significant complexity on designing parts, components and subsystems
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
• Create/update complex design control documents including requirement specs, and risk documents with robust knowledge on design control requirements
• Develop project plans to assess technology and drive project results
• Train, coach, and guide lower level employees on more complex procedures
• Other incidental duties

Education and Experience:

• Bachelor's Degree in in Engineering or Scientific field with 6+ years' experience, including either industry or industry/education is required -OR-
• Master's Degree or equivalent in in Engineering or Scientific field with 5+ years' experience, including either industry or industry/education is required -OR-
• Ph.D. or equivalent in in Engineering or Scientific field with 2+ years' experience, including either industry or industry/education is required

Preferred Qualifications:

• Previous Class III medical device experience
• Experience in complex mechanical delivery systems
• Knowledge and understanding of design control, with emphasis on design verification/validation

Additional Skills:

• Proficiency in the usage of relevant computer software (Solidworks)
• Excellent documentation and communication skills
• Excellent interpersonal relationship skills including negotiating and relationship management skills
• Extensive knowledge and understanding of principles, theories, and concepts relevant to Engineering
• Advanced problem-solving, organizational, analytical and critical thinking skills
• Extensive understanding of processes and equipment used in assigned work
• Ability to influence others
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Must be able to work in a team environment, including frequent inter-organizational and outside customer contacts
• Represents organization in providing solutions to difficult technical issues associated with specific projects
• 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

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.

For California, the base pay range for this positio