Principal Engineer, R&D, Delivery Systems

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 patients unmet clinical needs. Its 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:

We are seeking a Principal Delivery System Engineer to play a key role on the next generation EVOQUE transcatheter tricuspid valve replacement this role you will serve as a lumen and subsystem owner responsible for advancing critical catheter subassemblies from early concept through design freeze and into later phases supporting commercial launch. You will collaborate closely with a dedicated team of R&D engineers and cross-functional partners to bring the next generation EVOQUE platform to marketcontributing directly to a transformative therapy aimed at improving outcomes for patients with tricuspid valve disease.

• Contribute to the development of a nextgeneration transcatheter tricuspid valve replacement system by applying clinical insights and learnings from previous device generations to advance the design and address unmet patient and user needs.

• Lead concept development and prototype iteration internally and with external vendors applying datadriven evaluation and clearly communicating findings and recommendations.

• Own and manage the design and budget of catheter and lumen subsystems from concept selection through design freeze and into verification and validation.

• Identify and resolve complex design challenges by balancing mechanical performance targets (e.g. tensile strength flexibility profile) with clinical performance needs (e.g. echogenicity stability) and manufacturability requirements.

• Work closely with crossfunctional teams in preclinical and clinical environments to guide design decisions informed by cardiovascular anatomy heart structure and valve pathology.

• Generate IP engineering models and drawings; coordinate prototype builds; and develop project plans to assess product designs and drive project results.

• Maintain accurate documentation of concepts designs drawings and procedures. Develop complex system test methods and generate written protocols reports and technical justifications/summaries.

• Create and update complex design control documents including requirement specifications and risk documents with robust knowledge of design control requirements.

• Oversee R&D support activities; provide direction on prototyping and testing; and train technicians/engineers while providing constructive feedback.

• Interface with Clinical Development Manufacturing Quality Marketing and vendors/suppliers to ensure compliance with internal policies and procedures FDA regulations and ISO standards.

What youll need (Required):

• Bachelors Degree in Engineering or Scientific field with a minimum of 6 years of experience -OR- Masters Degree or equivalent in Engineering or Scientific field with a minimum of 5 years of experience -OR- Ph.D. or equivalent in Engineering or Scientific field with a minimum of 2 years of experience

• Direct experience designing and building catheter-based delivery systems

• Proficiency with Creo/ProE or SolidWorks

What else we look for (Preferred):

• SolidWorks experience preferred

• Handson experience designing and manufacturing interventional catheters of various types (e.g. steerable catheters sheaths echogenic catheters internal lumens etc. consisting of polymers metals braids coils cables wires radiopaque markers laser cut hypo tubes multi-lumen extrusions etc.).

• Demonstrated track record of effective efficient collaboration with vendors and internal development partners or supporting organizations including: extrusions polymers textiles catheters and metals processing.

• Experience with various polymer components used for catheter construction including liner jacket tie layer and heat shrink used in reflow and tipping operations with braided coiled or laser cut tube shafts.

• Experience supporting interventional procedures in a clinical setting (physician training device prep procedure planning device proctoring etc.)

• Experience with laser cutting/welding

• Experience with machining and injection molding

• Able to evaluate how a part or subassembly integrates with impacts and is impacted by the broader system around it.

• Able to manage conflicting design priorities with composure and creativity finding balanced solutions or innovative ways to meet multiple needs.

• Must demonstrate a proven strength in applying relevant knowledge and judgment as a creative innovator strategic problem solver and technical leader.

• Must be passionate highly collaborative and willing to engage in productive creative debate.

• Must be highly motivated driven and able to tackle challenging technical problems independently with minimal supervision.

• Must be disciplined and organized to effectively plan execute document analyze and communicate learnings and design development progress.

• Must have a strong hands-on mechanical aptitude and flexibility to work in a dynamic environment.

• Must have effective verbal and written communication listening and diagnostic skills. The ability to collaborate effectively and gain support from crossfunctional teams and stakeholders is key to successfully delivering results.

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 $121000 to $171000 (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.