Edwards Lifesciences
Specialist, Clinical Development
USA - California – Irvine
Sponsorship not specified$87k-$123kDetected 67 days ago
GCPProduct ManagementAR/VRClinical TrialsMedical DevicesResearchCommunicationProblem SolvingCritical ThinkingMicrosoft OfficeGxP
Stay score
odds of building a lasting career here
50Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →Employer immigration record
from this employer's Department of Labor filings
Green-card filing pattern in this occupation
Context, not a finding about this posting: of this employer's 14 green-card filings in this occupation, 100% were for a worker who already held the job.
Green-card follow-through: 50%
Of 10 labor certifications old enough to have been used, 5 expired without the employer filing the next step. Median time from filing to decision: 493 days.100% of their filings were for a worker who already held the job.Only certifications past the 180-day window are counted — recent ones cannot have expired yet.
Reported a layoff in this occupation
In a green-card filing decided 2026-06-04, this employer stated it had laid off workers in Quality Control Systems Managers (CA) during the preceding six months. 2 such filings on record.Describes the period before that filing, not necessarily today. Unlike WARN notices this is occupation-specific and federal.
Files H-1B transfers
3 transfer filings in the last year, covering 3 workers. Median labor-condition decision: 8 days. An employer that already files transfers is one that can take over an existing H-1B.
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
No reports yet — be the first to help the next applicant.
About the role
- We're dedicated to pioneering next-generation innovations for patients with aortic regurgitation (AR).
- We're working together to transform cardiovascular care and device development to address unmet patient needs in structural heart disease.
- Ensure medical and scientific factors are considered during cross-functional product development project team meetings.
Responsibilities
- Develop and implement pre-clinical test strategy and provide guidance to team members on strategy execution
- Design, prepare and conduct first-in-man product evaluations, including case support for proper product use
- Create Clinical Investigator Brochure
- Design, develop, conduct, and assess results of post-market evaluations
- Develop, review, and update clinical design control documents including 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 moderately complex 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.
- Ability to manage confidential information with discretion
- Ability to manage competing priorities in a fast paced environment
- Ability to build productive internal/external working relationships
Requirements
- Provide product expertise for new product introduction training for clinical and site personnel
- Bachelor's Degree in biological or Lifesciences field
- Evaluate collected data documentation and imaging media, draw findings, and make recommendations to complete product evaluations, product complaint review and other required interim or final reports.
- What you'll need (required):
- Bachelor's Degree in engineering
- Experience with documentation management systems (e.g., Ignite)
Nice to have
- What else we look for (preferred):
Compensation
- For California (CA), the base pay range for this position is $87,000 to $123,000 (highly experienced).
Benefits
- Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical studies
- Moderate knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
- 3 years previous related experience in Class II and III medical device technologies and/or clinical studies background
Company info
- Join us and be part of our inspiring journey.
Apply directly at Edwards Lifesciences →Create a free account for alerts like thisView Edwards Lifesciences immigration profile
This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.