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Edwards Lifesciences · 1 day ago

Senior Supplier Quality Engineer, New Product Development

Salt Lake City, UT

Full-time

Onsite

Mid, Senior Level

3+ years exp

Edwards Lifesciences is a company dedicated to developing groundbreaking technologies that improve patient lives. They are seeking a Senior Supplier Quality Engineer to lead critical new product development projects, focusing on supplier qualification and collaboration across various teams to ensure product integrity and safety.

BiotechnologyHealth CareMedicalMedical Device

Comp. & Benefits

H1B Sponsor Likely

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

Supplier Quality EngineeringTest Method ValidationStatistical TechniquesRisk ManagementGD&TManufacturing ProcessesRoot Cause AnalysisCollaborationProblem Solving

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

Glassdoor4.0

Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.

Founded in 1958

Irvine, California, USA

10001+ employees

http://www.edwards.com

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)