Job description

This is a unique opportunity to join an innovative and challenging program within Edward's Transcatheter Tricuspid and Mitral Technologies Clinical Development team. The Principal Engineer, Clinical Development will work with cross functional project teams to drive the clinical success of PASCAL within TMTT.

Key Responsibilities:
Initiate and lead in the improvement, design and optimization of highly complex experiments and tests, analyze results, and provide complex recommendations, based on engineering principles.

Lead complex cross-functional investigations related to procedural use, including developing test strategies, overseeing engineers/technicians, and generating substantial reports.

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

Train, coach, and guide lower level employees on more complex procedures.

Proactively identify issues, achieve resolution, and resolve problems of highly significant complexity on designing parts, components and subsystems.

Provide direction and guidance on strategies related to procedural use and testing for investigations.

Required Qualifications:
Bachelor's Degree in Engineering with a minimum of 6 years of relevant experience; OR Master's Degree in Engineering with a minimum of 5 years of relevant experience in the medical device industry

Strong understanding of statistical techniques and test method development

Must be able to work in cross-functional teams and have a proven ability to cultivate collaboration across multiple disciplines (marketing, regulatory, quality, R&D, and usability engineering) to ensure project success

Strong in-depth experience and knowledge with root cause analysis and investigative techniques

Ability to travel up to 25% (internationally and domestically)

General Expectations:
Well-organized: accustomed to high standards of written and verbal communication and maintaining excellent records of correspondence.

Results oriented, positive “can do” attitude with a demonstrated a sense of urgency.

A “hands-on” individual who enjoys a challenge and is capable of getting the job done with minimal direction.

Good presentation skills; ability to present material comfortably. Good teamwork, networking, communication (written/verbal) and win-win relationship building skills.

Ability to build stable working relationships internally.

Candidate is required to fully comply with all US and Global regulations, and SOPs in the execution of all job duties.

Quick learner; ability to come up to speed quickly on Edwards’ products and service.

Ability to work positively through confrontation and/or conflicting ideas.

Represents organization in providing solutions to difficult technical issues associated with specific projects.

Ability to influence others.

Strong time management skills.

Additional Skills & Preferred Qualifications:
Clinical development and design validation strategy experience
Leading and/or providing support with New Product Development & Improvement (Class III devices highly preferred)
Experience collaborating with field specialists and/or physicians and collecting feedback on clinical use of products
Familiarity and strong knowledge of Risk Management and Usability Engineering
Willingness and ability to mentor less experienced engineers

This position is based out of Irvine, CA. Must live within a commutable distance or be able to relocate.

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 $106,000 to $151,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Know your Rights: Workplace Discrimination is Illegal Poster
Disability accommodation for employment applicants
Edwards E-Verify
Family and Medical Leave Act (FMLA)
Employee Polygraph Protection Act (EPPA)
Pay Transparency Notice

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