Principal Supplier Quality Engineer, Component New Product Development

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. 

**This is an onsite position with a work location based at our main Irvine campus.

The Principal Supplier Quality Engineer will play a key role on a critical project within the Transcatheter Heart Valve (THV) business unit. 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. The primary focus of the position is leading successful part qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life-saving medical devices. The Principal 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.

How you will make an impact:

• Ensure validation methods of critical suppliers and incoming quality control are aligned with international standards, global regulations, and industry best practices.
• Support completion of Design File requirements applicable to supplied component, sub-assemblies, devices, and services.
• Lead investigations of complex product quality and compliance issues (e.g., CAPAs, non-conformances, audit observations and findings, etc.) related to supplier manufacturing processes based on engineering principles; and analyze results, make recommendations, and develop reports.
• 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 based on engineering principles; analyze results, make recommendations, and develop reports and collaborate with team members to drive project completion.
• Ensure the optimization of complex 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.
• 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.).
• Train, coach, and guide lower-level employees on Supplier Quality procedures and responsibilities.
• Conduct on-site supplier audits.
• Other incidental duties: May drive portions of a project.

What you'll need:

• Bachelor's Degree in Engineering or Scientific field with 6 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR a Master's Degree in Engineering or Scientific field with 5 years of experience in either Supplier Quality, Manufacturing, New Product Development/Improvement, or Quality Engineering functions; OR a Ph.D. in Engineering or Scientific field with 2 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.
• Demonstrated Project Management Experience.
• Demonstrated leadership capabilities in coaching/guiding less seasoned engineers and teammates.
• Must have ability to travel up to 25% (both domestically and internationally)

What else we look for:

• Experience with supplier/vendor management and qualification activities with new suppliers, CMOs (Contract Manufacturing Organizations), 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 design and creation of inspection fixtures using SolidWorks.
• In-depth understanding and experience with risk management for validation qualifications (e.g. equipment or process OQ/PQs).
• Knowledge o