Principal Supplier Quality Engineer, Product Development

Please note that 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 optimizing product development to impact patients around the world with pioneering technology.

The Principal Supplier Quality Engineer will mentor engineers & technicians; provide direction and oversight of supplier quality activities; and play a key role leading critical projects that support our COE (Center of Excellence) for Metals and Advanced Catheter Delivery System. This position is cross‑functional in nature and requires strong collaboration and partnership with R&D, Design Assurance, Operations, Regulatory Affairs, Marketing, Sourcing, Supplier Development Engineering and Receiving Inspection.

This engineer will not only manage stakeholder relationships but also lead successful parts qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life‑saving medical devices. The engineer will work on‑site in a very fast‑paced and dynamic environment where being proactive and taking initiative are paramount to success.

• 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.

• 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

• Engineering…