Edwards Lifesciences · 15 hours ago
Principal Engineer, Supplier Quality
Irvine, CA
Full-time
Onsite
Senior Level, Lead/Staff
$118K/yr - $167K/yr
5+ years expEdwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. The Principal Engineer, Supplier Quality will play a key role in leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines for innovative medical devices.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
The Principal Engineer, Supplier Quality will reside in the Transcatheter Heart Valve (THV) Supplier Quality Engineering team to provide quality engineering support in the design and development of implantable device delivery systems to treat cardiovascular disease
Conduct supplier quality engineering activities from the initial product development phase through product launch
Provide technical input for supplier selection, including evaluation of supplier capability, part qualification plan requirements, specification review, product implementation and part transition to manufacturing
Develop and optimize test methods at Receiving Inspection and Supplier (e.g., vision system routines, fixturing design, measurement system analysis, test method SOPs, etc.) to meet new component requirements and product demands and complete test method validations
Support manufacturing readiness reviews, supply chain readiness reviews, and manage design transfers to production environment
Manage product phase in/phase out activities around design, regulatory and clinical requirements
Lead supplier part qualification plan activities, support milestone new product development build component readiness and commercialization of new product introduction. Transfer receiving inspection of new components into manufacturing locations
Conduct drawing reviews to ensure inspection DFX considerations are incorporated into designs. Report test method outputs of component critical features and drive/influence drawing changes where warranted
Participate in technical discussions with suppliers to identify and implement improvements in products and processes
Respond with a high sense of urgency to quality issues and escalate / communicate appropriately
Strategically bring various cross functional teams and suppliers in alignment on outstanding issues in a timely manner
Perform audits of approved suppliers' quality management system and act as Supplier Quality subject matter expert on cross-functional technical assessments of suppliers that are being considered for addition to the approved supplier list
Lead investigations of supplier component quality and compliance issues
Train, coach, and guide less-senior team members on more complex procedures/requirements
Drive portions of a project, including acting as the project manager for all Supplier Quality tasks in support of the Edwards new product development process and project milestones, and reporting on status of deliverables at cross-functional project forums
Oversee Quality support tasks; provides instruction, training, and feedback to engineers, technicians, and inspectors on component test methods
Perform other duties and responsibilities as assigned
Qualification
Required
Bachelor's degree in engineering or scientific field with 6 years of experience in either Supplier Quality, Manufacturing Engineering, New Product Development/Introduction, or Quality Engineering functions; OR a Master's degree in engineering or scientific field with 5 years of experience in either Supplier Quality, Manufacturing Engineering, New Product Development/Introduction, or Quality Engineering functions
Must be willing to work on-site
Ability to travel up to 20% (domestic & international)
Preferred
Experience with supplier/vendor management and qualification activities with new suppliers
Experience in medical device, pharmaceutical, or other highly regulated industries (e.g., aerospace, automotive with strong regulatory compliance)
Experience in catheter assembly and related sub-assembly components manufacturing technologies in the development of cardiovascular and/or endovascular devices, minimally invasive endoscopy and implantable devices
Experience creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks
Strong knowledge of DFM/DFx, component design reviews, and manufacturing capability assessment
Hands-on experience with supplier validations, including IQ/OQ/PQ, process validation, and capability studies
Proven ability to evaluate supplier technical capability, including auditing, risk assessments, and capacity reviews
Experience supporting or leading new product introduction (NPI), design transfer activities, and manufacturing readiness evaluations
Proficiency in statistical analysis and use of quality tools (Six Sigma, DMAIC, DOE, SPC, Gage R&R, pFMEA, dFMEA, etc.)
Demonstrated ability to troubleshoot complex quality issues and drive root cause & corrective action (RCCA)
Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 risk management
Proven ability to lead cross‑functional deliverables/efforts (R&D, Quality, Manufacturing, Supply Chain, Supplier Management)
Strong project management skills, including structuring project milestones
Certifications such as ASQ CQE, CQA, CSSGB/CSSBB, or Six Sigma Black Belt
Proven expertise in usage of MS Office Suite
Benefits
Competitive salaries
Performance-based incentives
A wide variety of benefits programs
Company
Edwards Lifesciences
Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.
10001+ employees
H1B Sponsorship
Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (81)
2024 (70)
2023 (42)
2022 (65)
2021 (44)
2020 (28)
Funding
Current Stage
Public CompanyTotal Funding
unknown2000-04-03IPO
Leadership Team
Bernard J. Zovighian
Chief Executive Officer
Harry Rowland
SVP IHFM Innovation (Implantable Heart Failure Management)
Recent News
2026-01-07
Orange County Business Journal
2026-01-04
BioWorld Financial Watch
2025-12-25
Company data provided by crunchbase