Edwards Lifesciences
Principal Engineer, Supplier Development
USA - California – Irvine · Principal
Sponsorship not specified$121k-$171kDetected 80 days ago
Project ManagementProcess ImprovementGD&TPatient CareFDA RegulatoryMedical DevicesLeadership
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odds of building a lasting career here
57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70
Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). 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
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About the role
- Many structural heart patients suffer from heart failure with limited options.
- Our Implantable Heart Failure Management (IHFM) team is at the forefront of addressing these unmet patient needs through pioneering technology that enables early, targeted therapeutic intervention.
- Our innovative solutions are not just transforming patient care but also creating a unique and exciting environment for our team members.
Responsibilities
- Supplier Validation and Product Development Process: Lead the end-to-end technical validation of suppliers during product development, from component design and GD&T reviews to process characterization, capability analysis, and strategic process validation, ensuring robust DFM/DFA integration and quality compliance across all development stages.
- Build and maintain strong partnerships with R&D, Program Management, Manufacturing, Supplier Quality, and key suppliers to ensure seamless project execution and compliance with internal procedures, QSR, FDA regulations, ISO 13485 standards, and risk management best practices.
- Support and contribute to product development efforts by influencing the design and iteration of next‑generation systems and components for IHFM.
- Lead cross‑functional teams and external suppliers in the design, development, and testing of complex interventional catheter delivery systems for implantable devices.
- Perform other duties and responsibilities as assigned.
- Background in at least two of the following areas: interventional access devices, rapid product development, component-level manufacturing, or complex assembly design.
- Proven ability to manage and collaborate with external vendors to meet quality, timeline, and technical requirements.
- Strong experience in rapid product development within cross‑functional teams, including creative design iteration, prototyping, and test method development (e.g., in‑vitro testing).
Requirements
- Oversee and drive timelines for feasibility studies, design verification testing, clinical evaluations, and supplier validation activities required for commercial release.
- Bachelor's degree in engineering or scientific, with 6 years of experience in new product development, process development, commercialization, and/or operations engineering in a highly regulated environment.
- What you'll need (Required):
- Master's degree in engineering and/or MBA.
- Hands-on experience with electronic manufacturing processes.
Nice to have
- What else we look for (Preferred):
Compensation
- For California (CA), the base pay range for this position is $121,000 to $171,000 (highly experienced).
Benefits
- Strong background in sensor based medical device development, with hands-on experience in design optimization and advancing innovative technologies from concept through commercialization.
- The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Company info
- Join us and be part of our inspiring journey.
Equal opportunity
- Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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This listing is sourced directly from Edwards Lifesciences's careers page and normalized into a canonical job model.