Senior Engineer, R&D

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

Job summary

Edwards Lifesciences in Irvine, CA is seeking a Senior Engineer, R&D to design, develop, and qualify the next-generation SAPIEN M3 platform for TMVR. You will collaborate with Quality, Manufacturing, Clinical, and Regulatory teams to address unmet clinical needs and advance innovative heart-disease solutions.

The role requires a engineering or scientific degree and 3–4+ years of experience, with strong documentation and leadership potential.

Qualifications

• Bachelor's degree in Engineering or Scientific field with 4+ years of experience OR Master's with 3+ years of experience.
• Medical device industry experience is highly preferred.
• Strong documentation, communication and interpersonal skills.

Responsibilities

• Work in a cross-functional environment (Quality, Manufacturing, Clinical, Regulatory) to support new product development.
• Create, test, and/or improve products by developing complex experiments and tests, analyze results, and develop reports.
• Generate work instructions, test methods, engineering models and drawings to establish specifications.
• Develop and execute engineering project plans
• Identify, evaluate, manage, and provide guidance to suppliers with defined acceptance criteria
• Train technicians and coordinate technician work
• Interact with senior personnel on significant matters and coordinate between organizations

Skills

Cross-functional collaboration

Documentation

Communication

Problem solving

Leadership

Analytical thinking

Team coordination

Education

Bachelor's degree in Engineering or Scientific field

Master's degree in Engineering or Scientific field

Tools

CAD

MS Office Suite

Quality systems

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.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Senior Engineer, R&D will play a key role in designing, developing, and qualifying the next-generation SAPIEN M3 platform, applying technical expertise and a strong understanding of Edwards systems and processes. The SAPIEN M3 is a transcatheter mitral valve replacement (TMVR) system designed to treat mitral regurgitation (MR) in patients deemed unsuitable for surgery or transcatheter edge-to-edge repair (TEER). The system utilizes a two-stage approach: a nitinol "dock" that anchors around the native mitral valve and a balloon-expandable SAPIEN 3 valve adapted for the mitral position.

How you’ll make an impact:

• Work in a cross-functional environment (Quality, Manufacturing, Clinical, and Regulatory) to support new product(s) development.
• 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
• Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
• Create/update more complex design control documents including requirement specs, and risk documents
• 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
• 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 in Engineering or Scientific field with 3+ years of experience

What else we look for (Preferred):

• Medical device industry experience is highly preferred
• Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
• Knowledge of materials and processes for shaft construction, injection molding is a plus
• Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
• Proven expertise in usage of MS Office Suite; CAD experience preferred
• Basic understanding of statistical techniques
• Previous experience working with lab/industrial equipment required (if applicable)
• 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
• 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.

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