Engineer I, NPD

Edwards Lifesciences • Irvine, CA

14h • Onsite

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 New Product Development Engineering team, you will work closely with our R&D and Quality teams to develop the latest tools and technologies to address significant, unmet clinical needs that impact patients’ lives around the world. Aortic stenosis impacts millions of people globally, yet it often remains 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. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelor's Degree in Engineering or Scientific field
• Demonstrate strong proficiency in MS Office Suite (including MS Project)
• Apply clear written and verbal communication skills with strong interpersonal effectiveness
• Demonstrate a basic understanding of statistical techniques
• Apply foundational engineering principles, theories, and concepts
• Solve problems effectively using strong organizational, analytical, and critical thinking skills
• Demonstrate understanding of processes and equipment relevant to assigned work
• Adhere to Edwards Environmental Health & Safety and Quality guidelines, including clean room medical device manufacturing standards
• Maintain strict attention to detail
• Interact professionally across all organizational levels
• Manage competing priorities effectively in a fast-paced environment
• Collaborate effectively in a team environment, including working with supervisors, cross-functional teams, and external vendors
• Build and maintain stable internal working relationships
• 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

Nice To Haves

• CAD experience preferred, if applicable
• Show experience working with lab or industrial equipment, if applicable

Responsibilities

• Support design control activities for manufacturing product and process development
• Develop manufacturing documentation (drawings, SOPs, routers, pFMEA) across various release stages and create training materials to enable seamless knowledge transfer to production
• Support process definition and development of process controls
• Provide operations input into specifications (DFx, tolerancing, material selection, automation), supporting stability metrics and risk mitigation through SCRR and MRR
• Collaborate on build strategy, prioritization, and technical support for QST, pre-DV, and DV; partner with Pilot on root cause investigations prior to commercialization
• Support development and execution of experiments and test protocols to characterize and refine processes; assist with qualifications and validations (IQ, OQ, software)
• Support manufacturing equipment engineering and tooling design for program-specific needs
• Assist in analysis of manufacturing and compliance issues (CAPA, non-conformances, audit observations) and support process transfer activities
• Identify opportunities to redesign equipment, tools, and fixtures to improve manufacturing processes
• Drive continuous improvement using engineering methods (LEAN, basic statistics)
• Perform other duties as assigned by leadership

Benefits

• competitive salaries
• performance-based incentives
• 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: Entry Level