Edwards Lifesciences · 9 hours ago
Principal Supplier Quality Engineer, New Product Development
USA - Utah – Salt Lake City
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expEdwards Lifesciences is a leading company focused on innovative medical technologies, and they are seeking a Principal Supplier Quality Engineer for their New Product Development team. This role involves mentoring engineers, overseeing supplier quality activities, and leading projects that support the development of life-saving medical devices through collaboration with various teams.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead complex, medium-scale projects with significant business impact, ensuring successful delivery of all milestones. Develop and manage project plans, schedules, and quality objectives while applying engineering expertise to evaluate and improve supplier designs and processes for new to market devices and novel technologies
Lead root cause investigations of complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations and findings, etc.) related to supplier manufacturing processes
Lead the development and execution of complex experiments and test methods (including writing and executing protocols) to validate and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods
Lead deliverables specific to component engineering per the Product development process including concept, early human use, clinical and commercialization phases while ensuring high standards for quality compliance and product safety
Ensure the optimization of complex internal and supplier manufacturing processes using engineering methods (e.g., Six Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of more complex equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices
Develop technical content of risk management files
Develop training and documentation materials on component test methods for Receiving Inspection (e.g., test method procedures, inspection routers, etc.)
Conduct on-site supplier audits
Provide training, coaching, and mentorship to engineers on Supplier Quality procedures and responsibilities
Qualification
Required
Bachelor's degree with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR Master's degree with 5 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions
Well-versed in statistical tools such as Gage R&R, Statistical Process Control, Process Capability Studies, Hypothesis Testing, and other statistical techniques related to manufacturing
Project Management Experience
Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates
Highly regulated industry experience
Preferred
Engineering degree
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products
Experience with CAPAs, NCRs, Change Notifications, and/or Auditing
Demonstrated experience driving component testing, test method validations, and testing/validating equipment
Experience creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks
In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs)
In-depth knowledge of manufacturing process for shaft manufacturing, injection molding and extrusions
Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices
Six Sigma Green or Black Belt Certified
Benefits
COVID Vaccination Requirement
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
Orange County Business Journal
2026-01-14
2026-01-13
Medical Device Network
2026-01-13
Company data provided by crunchbase