Job description

This is a unique opportunity to join the Transcatheter Mitral and Tricuspid Therapies Unit (TMTT) group, focused on developing minimally invasive solutions for patients suffering from structural heart disease. This individual will join a tight knit, fast-paced, dynamic team and play a pivotal role in the development of new repair therapies and devices, from concept through to human use, training Heart Teams on the use of the technologies, and providing case support for clinical sites in the on-going clinical trials.

The Sr. Manager Clinical Education will provide expertise and clinical insights on the device, procedure, and protocol throughout the product life cycle from early studies through commercialization.

Responsibilities include, but not limited to:
Clinical: Lead team to represent TMTT during complex cases (ESAPCU, clinical trial and commercial) with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during procedures, including contingency planning to address unforeseen occurrences in support of TMTT devices.

Oversee details of the pre-procedural planning, procedural steps, and post-procedural debriefs, and documentation of procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team

Provide education on all aspects of the device, device handling, implantation and troubleshooting techniques related to equipment, tools and products required for device implants.

Technical: Provide therapy oversight of the development and analyses of the complex procedures and testing leveraging SME-level clinical engineering expertise to ensure technical inputs are fed into next generational design. Provide leadership of and coordination of all clinical engineering training and instruction for cross-functional teams as products move from EASPCU to early human use to the commercial setting. Provide technical leadership guidance complex design control and trial-related documentation and support of all complaint and investigational analyses supporting the therapy. Provide expert strategic direction and initiative in all clinical engineering projects to leadership.

Lead team to educate and train physicians, hospital personnel and hospital staff on technical matters related to investigational products and procedures through conducting and/or coordinating one-on-one ad hoc training sessions and in-service structured education programs.

Minimum Education and Experience Requirements:
Bachelor's Degree in in Engineering or Scientific field, 8 year’s experience including either industry or industry/education or

Master's Degree or equivalent in in Engineering or Scientific field, 7 year’s experience including either industry or industry/education or

Ph.D. or equivalent in in Engineering or Scientific field, 4 year’s experience including either industry or industry/education

Required Skills

Recognized as an expert in own area within the organization.

Expert knowledge and understanding of principles, theories, and concepts relevant to Engineering and cardiovascular science.

Advanced problem-solving, organizational, analytical and critical thinking skills
Expert understanding of medical device regulatory requirements and documents, and adverse events reporting.

Works on unusually complex technical problems and provides solutions which are highly innovative and creative.

Interprets internal or external business issues and recommends solutions/best practices.
Represents organization as key technical contact on contracts and projects.

Interacts with senior external representatives on significant technical matters often requiring coordination between organizations.

Proficiency in the usage of relevant computer software.

Excellent documentation and communication skills.

Excellent interpersonal relationship skills including negotiating and relationship management skills.

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.

Travel (day and overnight by car, air, train, etc.) will vary. Percentage of time is determined by Management.

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 $166,000 to $235,000 (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.
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Disability accommodation for employment applicants
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Family and Medical Leave Act (FMLA)
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