Principal Engineer, R&D - Irvine, CA

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 w ...

Job description

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:

• 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

What you'll need (Required):

• 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

What else we look for (Preferred):

• 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

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 (CA), the base pay range for this position is $118,000 to $167,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.