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. Clinical Specialist 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: Represent TMTT during complex research cases (ESAPCU, clinical trial, commercial) with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during implants, including contingency planning to address unforeseen occurrences in support novel devices

CLINICAL: Develop materials and 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: Develop, analyze, and optimize the design of complex procedures, testing, and therapies leveraging substantial understanding of clinical engineering. Coordinate and conduct clinical engineering training and instruction for cross-functional teams as products move from EASPCU to early human use to the commercial setting. Create complex design control and trial-related documentation and support all complaint and investigational analyses supporting the therapy. Make recommendations for improvements.

CLINICAL: Document procedural case observations for insights in investigating post procedural events. Support enrollment discussions and assistance with issue escalation with Principal Investigator and research team

Minimum Education and Experience Requirements:
Bachelor's Degree in Engineering or Scientific field - 4 years
Master's Degree or equivalent in Engineering or Scientific field - 3 years

Required Skills

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

Full knowledge of cardiovascular anatomy, pathology and physiology

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

Substantial understanding of medical device regulatory requirements and documents, adverse events reporting

Good leadership skills and ability to influence change

Proven expertise in usage of MS Office Suite;

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 preferred

Knowledge of and adherence to Edwards Environmental Health and Safety and Quality guidelines as they relate to department clean room medical device manufacturing

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, the base pay range for this position is $125,000 to $177,000 (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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