Senior Supplier Quality Engineer, Product Development

Senior Supplier Quality Engineer, New Product Development Type

Full time

USA - Utah – Salt Lake City

Req-44908

6 days ago

Please note this is an onsite role, and the successful candidate will be expected to work from our Draper, UT facility.

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision‑making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

The Senior Supplier Quality Engineer will play a key role on critical new product development projects for metals. This position is cross‑functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Supplier Development Engineering and Receiving Inspection. The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines.

The Supplier Quality Engineer will work on‑site in a very fast‑paced and dynamic environment where being proactive and taking initiative are paramount to success.

• 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 Solid Works.
• 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.
• 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.

• 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%

• 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.).

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world‑class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient‑focused culture to deliver life‑changing innovations to those who need them most.

Edwards Lifesciences is an equal opportunity employer. We believe that diversity and inclusion are essential to creating an environment where all our employees can grow and thrive. Guided by our values of integrity and service, we are committed to maintaining a culture of inclusivity and belonging by creating a welcoming workplace for people of all backgrounds.

Edwards Lifesciences is committed to providing reasonable accommodations and adjustments to individuals with a disability or neurodivergence. If you need an accommodation or adjustment during the application, interview, or hiring process, please see the disability accommodation section below.