Engineer II, R&D

Edwards Lifesciences • Irvine, CA

1d • 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 R&D Engineering team, you 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 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. The Engineer II is part of the THV R&D implant development team. The role of the team is to design, develop and set up manufacturing processes of valves that are best in class to achieve the THV R&D group mission. The team is also a strong partner with the Global Supply Chain & Operations group in order to launch these innovations to help patients. The position specifically will focus on pre-commercial R&D manufacturing and process development.

Requirements

• Bachelor's Degree in Engineering or Scientific field, 2 years experience - OR – Master's Degree or equivalent with internship, senior projects, or thesis in Engineering or Scientific field including either industry or industry/education

Nice To Haves

• CQE (Certified Quality Engineer), if applicable
• Good computer skills in usage of MS Office Suite including MS Project; CAD experience preferred (if applicable)
• CAD experience in Solidworks or CREO
• Good documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Basic understanding of statistical techniques
• Solid problem-solving, organizational, analytical and critical thinking skills
• Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing
• 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 the ability to manage vendors and project stakeholders
• Ability to build productive internal/external 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

Responsibilities

• Create, test, and/or improve products by developing moderately complex experiments and tests , analyze results, make recommendations, and develop reports, based on engineering principles
• Optimize manufacturing processes, including using engineering methods (e.g., SIX Sigma) for continuous process improvement and/or re-design/design of equipment, tools, fixtures, etc. to improve manufacturing processes, employing technical design skills
• Generate work instructions, test methods, engineering drawings/prototypes, etc. to establish/characterize product and/or process specifications
• Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
• Create/update portions of design control documents including requirement specs and risk documents
• Assign R&D & Manufacturing support tasks; gives instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers

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: Mid Level