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.
How you will make an impact:
- 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.
What you’ll need (Required):
- 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
- Ability to work 100% onsite at our Draper, UT location. This role is not eligible for remote or hybrid work arrangements
What else we look for (Preferred):
- Engineering degree
- 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).
- In-depth knowledge of manufacturing process for shaft manufacturing, injection molding and extrusions.
- Knowledge and understanding of FDA and international regulatory standards (i.e. ISO 13485 & ISO 14971) for medical devices.
- Six Sigma Green or Black Belt Certified.
