Principal Engineer, Sustaining R&D

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 and critical care. 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.

How you will make an impact:

This is an exciting opportunity for a passionate engineer to join our Sustaining R&D team for Evoque system (World’s first FDA approved Transcatheter Tricuspid Valve Replacement). This position is in our R&D group with primary responsibility of providing R&D support for cross-functions (Quality, Clin Dev, Operations) on all sustaining activities for our newly commercialized Tricuspid Valve replacement platform (EVOQUE).

• Support Sustaining R&D activities by applying engineering principles to evaluate field complaints, manufacturing issues and supply chain changes related to delivery system, implant and accessories.

• Develop complex experiments and tests (including writing and executing protocols), conduct failure analysis. Analyze results, make recommendations, and develop reports, based on engineering principles.

• Analyze incoming issues/complaints, evaluate trends, generate reports and summarize conclusions for cross-functional reporting.

• Generate test methods, engineering models, drawings and prototypes, etc., to evaluate and characterize product performance.

• Create/update more complex design control documents including requirement specs, and risk documents.

• Evaluate, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.

• Interface with Manufacturing, Clinical Affairs, Quality, Marketing, vendors/suppliers, to ensure compliance with internal and policies and procedures (QSR, FDA Regulations, and ISO Standards).

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

• 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.

**Must be willing to travel (Up to 25%)**

What you'll need (Required):

• Bachelor's Degree in Engineering or Scientific field with 6+ years' of related experience -OR-

• Master's Degree or equivalent in Engineering or Scientific field with 5+ years' of related experience -OR-

• Ph.D. or equivalent in Engineering or Scientific field with 2+ years of related experience

What else we look for (Preferred):

• Mechanical or Biomedical Engineering majors

• Experience with Class III medical devices in an engineering role.

• Proficiency in design (experience in CAD - Solidworks or Creo)

• Experience in complaint investigation, root cause analysis and/or sustaining engineering.

• Manufacturing or product development experience in complex catheters or delivery systems or cardiac implants.  

• 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 required.

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

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

• Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.

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, the base pay range for this position is $115,000 to $163,000 (highl