Edwards Lifesciences · 20 hours ago
Senior Supplier Quality Engineer, New Product Development
USA - Utah – Salt Lake City
Full-time
Onsite
Mid, Senior Level
4+ years expEdwards Lifesciences is a company focused on developing groundbreaking technologies to improve patient outcomes. The Senior Supplier Quality Engineer will lead part qualification efforts with external suppliers for new product development projects, ensuring compliance with quality standards and timelines.
BiotechnologyHealth CareMedicalMedical Device
Responsibilities
Lead/perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs
Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks
Manage component and supplier qualification activities from initiation to closure
Supports completion of Design File requirements applicable to supplied components, subassemblies, devices, and services
Create test method procedures and provide training. Provide engineering support to Receiving Inspection on component test methods and investigations
Conduct on-site supplier audits
Manage supplier-related non-conformances
Manage supplier corrective action requests from initiation to closure
Report on supplier part qualification status at recurring cross-functional project meetings
Qualification
Required
Bachelor's degree in Engineering or Scientific field with at least four (4) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities; OR Master's degree with three (3) years of experience with either supplier quality, quality engineering, manufacturing, new product development/improvement, or production engineering activities
Highly regulated industry experience
Must have ability to travel up to 20%
Preferred
Engineering degree
Medical Device, Aerospace, or Automotive industry experience
Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), or OEMs for new products
Demonstrated experience driving component testing, test method validations, and testing/validating equipment
Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies
In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process IQ/OQ/PQs)
Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as applied through CAPAs
Knowledge of GD&T and ability to read and interpret drawings
Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.)
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