Principal Engineer, R&D

Edwards Lifesciences•Irvine, CA

2d•$118,000 - $167,000

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 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. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. How you will make an impact: This is an exciting opportunity to join the Edwards Surgical R&D engineering organization. The Principal Engineer position will have high collaboration and work with different functions including R&D, quality, commercial manufacturing, global supply chain (GSC), regulatory and marketing. This engineer will learn and apply knowledge of technical principles and Edwards systems/procedures to support product life cycle management by optimizing product design, contributing to commercialization of new product, assisting the development of optimized manufacturing processes, and supporting regulatory submissions and marketing activities. The ideal candidate is a self- starter and has strong communication and collaboration skills, who has a strong desire to learn and is a quicker learner. Additional responsibilities include:

Requirements

Bachelor’s degree in engineering or Scientific field, with a minimum of 6 years of experience, including either industry or industry/education -OR- Master's Degree or equivalent in Engineering or Scientific field, with a minimum of 5 years of experience, including either industry or industry/education -OR- Ph.D. or equivalent in Engineering or Scientific field, with a minimum of 2 years of experience, including either industry or industry/education
Travel 10% domestically or internationally

Nice To Haves

Experience in combination of medical device R&D engineering, manufacturing and process development, especially in heart valve R&D engineering and manufacturing processes is highly preferred
Understanding medical device quality system, design control, and regulatory requirements
Medical device design and manufacturing experience in heart valves, stents, tissue, catheters, delivery systems and/or interventional access devices
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
Solid understanding and knowledge of principles, theories, and concepts relevant to engineering and statistical analysis techniques
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

Responsibilities

Lead in the improvement, design and optimization of more complex experiments, testing, 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
Partner with technical engineers on new products in the PDP process and its main interface between R&D, quality, pilot, supplier development, and commercial manufacturing
Provide relevant inputs and feedback to the development team on device design and manufacturability. As required, generate data or information through DOE, characterization studies, stack-up analyses, etc.
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerance and defining acceptance criteria for suppliers
Independently develop project plans to assess technology and drive project results
Train, coach, and guide lower-level employees on more complex procedures
Perform other duties and responsibilities as assigned