Manager, Supplier Quality - New Product Development

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

The Manager, Supplier Quality Engineering will manage a team of engineers and techs to 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 manager will not only manage stakeholder relationships but also lead successful part qualification efforts with external suppliers to support product development and commercial launch timelines for innovative and life-saving medical devices. The manager 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.
• Manage a team of supplier quality engineers, while driving talent development aligned with departmental growth strategies. 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 a 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

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.

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

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.