Principal Supplier Quality Engineer, Product Development

Overview

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.

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 (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 and manufacturing processes. Lead deliverables specific to component engineering across product development phases while ensuring high standards for quality compliance and product safety. Ensure optimization of complex internal and supplier manufacturing processes using Six Sigma and Lean methods for manufacturing design and continuous process improvement.

Identify opportunities for redesign of complex equipment, tools, fixtures 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 for risk management files. Develop training and documentation materials for component test methods for Receiving Inspection. Conduct on‑site supplier audits.

Provide training, coaching, and mentorship to engineers on Supplier Quality procedures and responsibilities.

• Bachelor’s degree with 6 years of experience in Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering; or Master’s degree with 5 years of experience in one of those 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 or guiding less seasoned engineers and teammates.
• Highly regulated industry experience.
• Ability to work 100% onsite at our Draper, UT location; this role is not eligible for remote or hybrid work arrangements.

• Engineering degree.
• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs, 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 designing and creating inspection fixtures using Solid Works.
• In‑depth understanding of risk management for validation qualifications (e.g., equipment or process OQ/PQs).
• In‑depth knowledge of manufacturing processes for shaft manufacturing, injection molding, and extrusions.
• Knowledge and understanding of FDA and international regulatory standards (ISO 13485 & ISO 14971) for medical devices.
• Six Sigma Green or Black Belt Certified.

Draper, UT – 100% onsite.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.