Senior Specialist, Clinical Development

Posted 11 days ago

edwards lifesciencesIrvine (CA)

Bioengineers and Biomedical Engineers Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

SALARY

$108,000 to $153,000

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About the role

Edwards Transcatheter Heart Valve Opportunity Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How you'll make an impact: Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians Ensures successful product lifecycle management for multiple complex projects, including:

Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy
Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
Create Clinical Investigator Brochure
Develop clinical trial strategy
Provide scientific rationale for product attributes and pre-clinical test results to regional clinical teams necessary to obtain site and country approvals
Provide product expertise for new product introduction training for clinical and site personnel
Design, develop, conduct, and assess results of post-market evaluations

Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, design of validation protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development. Ensure medical and scientific factors are considered during cross-functional product development project team meetings. Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports Consult with field trial managers to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance. Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports. Other duties as assigned by leadership

What you'll need:

(Required):Bachelor's Degree in biology or life sciences field, 5 years experience Class II and III medical device technologies and/or clinical studies background
Travel up to 50% nationwide
This position is based in Irvine, Ca full time on site.
What else we look for (Preferred):Bachelor's Degree in Engineering
Proven expertise with computer skills – Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet
Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
Experience with pre-clinical testing protocols, hospital environments and sterile techniques
Good communication and organizational skills
Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills
Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
Demonstrated problem-solving and critical thinking skills
Thorough, conscientious and results oriented working style
Team oriented
Ability to work in a dynamic work environment
Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)

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 (CA), the base pay range for this position is $108,000 to $153,000 (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.

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