Principal Supplier Quality Engineer – New Product Development
Edwards Lifesciences
full-time
Posted on:
Location Type: Office
Location: Salt Lake City • Colorado • Florida • United States
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Job Level
About the role
- 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.
Requirements
- 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
Benefits
- COVID Vaccination Requirement
- Employee Benefits Program
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementsupplier qualitymanufacturingnew product developmentquality engineeringstatistical toolsGage R&RStatistical Process ControlProcess Capability StudiesHypothesis Testing
Soft Skills
leadershipcoachingmentorshipcommunicationproblem-solving