Senior Engineer, R&D, Discovery

Edwards Lifesciences; Irvine, Northern (CA, KY); On-site; USD 108,000 - 153,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA is seeking an R&D engineer to support the Surgical unit, partnering with quality and manufacturing to advance tools for structural heart disease. You will participate in design activities, develop prototypes, and help translate unmet clinical needs into actionable engineering plans.

The role requires a engineering/science degree with relevant medical device experience and strong communication, leadership, and analytical skills.

Qualifications

• Bachelor's, Master's, or PhD in engineering or scientific field with required experience.
• Hands-on experience in the medical device industry is required.
• Direct experience with Class III devices is strongly preferred.
• Strong documentation and communication skills, with attention to detail.
• Knowledge of statistical techniques and lab/industrial equipment is a plus.

Responsibilities

• Create, test, and improve products by running complex experiments and writing protocols.
• Define unmet needs via literature reviews or VOC with health care practitioners.
• Collaborate with cross-functional teams on design activities and test methods.
• Develop concepts and prototypes; perform early concept development using predictive methods.
• Generate work instructions, models, drawings, and specifications; manage supplier relations.
• Lead engineering projects, guide technicians, and coordinate team tasks.
• Travel domestically and internationally up to 10% for congresses and events.

Skills

Team leadership

Communication skills

Analytical thinking

Problem solving

Education

Bachelor's Degree in Engineering or Scientific field

Tools

MS Office Suite

CAD

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:

As part of the Surgical R&D Discovery team you will:

• Create, test, and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles

• Define unmet needs through literature reviews or high-touch engagements such as voice of customer (VOC) with Health Care Practitioners (HCPs)

• Participate with cross functional teams through complex design activities including requirements identification, boundary condition definition, and test method and model development & validations

• Ideate and generate novel concepts and incept first designs and prototypes

• Perform early concept development by utilizing predictive engineering methods and tools (e.g. FEA, DOE) and collaborating with enabling technology R&D teams

• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications

• Develop and execute engineering project plans

• Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers

• Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work

• Evaluate input and form a technical recommendation including designing parts, components and subsystems

• Train, coach, and guide lower level employees on routine procedures

• Travel domestically and internationally to congress and society meetings, HCP and internal events, and to observe therapies (up to 10%)

• Other duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 4 years of experience -OR- Master's Degree or equivalent in Engineering or Scientific field with 3 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field

• Hands-on experience within the medical device industry

What else we look for (Preferred):

• Direct experience working with Class III devices strongly preferred

• Proven expertise in usage of MS Office Suite; CAD experience preferred

• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills

• Basic understanding of statistical techniques

• Previous experience working with lab/industrial equipment

• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering

• Strong problem-solving, organizational, analytical and critical thinking skills

• Substantial understanding of processes and equipment used in assigned work

• Good leadership skills and ability to influence change

• 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 inter-departmental teams and key contact representing the organization on contracts or projects

• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

• 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 $108,000 to $153,000 (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.