Edwards Lifesciences
Sr Specialist, Clinical Development
USA - California – Irvine · Senior · Full-time
Sponsorship not specified$108k-$153kDetected 7 days ago
GCPProduct ManagementExcelClinical TrialsPatient CareMedical DevicesLeadershipCommunicationProblem SolvingCritical ThinkingOrganizational SkillsMicrosoft OfficeGxP
About the role
- 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.
- It's our driving force to help patients live longer and healthier lives.
Responsibilities
- 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
- 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.
- 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
Requirements
- What you'll need (Required):
- Experience with pre-clinical testing protocols, hospital environments and sterile techniques
Nice to have
- Bachelor's Degree in engineering Preferred
- What else we look for (Preferred):
Compensation
- For California (CA), the base pay range for this position is $108,000 to $153,000 (highly experienced).
Benefits
- Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
- Bachelor's Degree in biology or life sciences field, 5 years experience Class II and III medical device technologies and/or clinical studies background Required
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This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.