Supplier Quality Engineer II, Process Validations & Test Methods

Imagine how your ideas andexpertisecan change a patients 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.Youllbring your passion for problem solving and partner with various teams to influence decision-making for a products entire lifecycle. Your work will involve youoptimizingproduct development toimpactpatients around the world with pioneering technology.

The Supplier Quality Engineer II will play a key roleoncritical projectswithin theTranscatheterMitral & Tricuspid Therapies (TMTT)business unit.This position is cross-functional in nature and requires strong collaboration and partnership with R&D Design Assurance Operations Regulatory Affairs Supplier DevelopmentEngineeringand 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. The Supplier Quality Engineer II 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:

• Facilitate/perform gage studies process capability studies and supplier process validations related to criticalcomponentfeatures based on risksidentifiedin FMEAs.

• Developandvalidatetest methods which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.

• Create test method proceduresandprovidetraining.Provide engineering support to Receiving Inspection oncomponenttest methodsand investigations.

• Supportcomponentspecification development identification of critical features development of inspection methods and plans test method validationprocessvalidationsandcomponentcapability assessments

• Supportsrisk management activities including the development and implementation of FMEAs process control plans and quality agreements at suppliers

• Utilize statistical techniques and six sigma tools to analyze processes and drive continuous improvement activities

• Conduct on-site supplier audits.

• Manage supplier-related non-conformances.

• Manage supplier corrective action requests from initiation to closure.

• Collect and analyze Quality metrics relating to Supplier Quality

• Communicate supplier quality risks to upper management during Management Review andprojectmeetings andidentifysolutions to mitigate risks.

• Support process and system improvement projects as assigned by manager

Whatyoullneed(Required):

• Bachelors degree in engineeringwith at least 2 years of experience witheithersupplier qualityqualitymanufacturingR&Dorproductionengineeringactivities; OR Masters degree with no experience (or internship/co-opexperience).

• Highly regulated industry experience

• Must have ability to travel up to25%

• Ability to work 100% onsite at our Irvine CA location.This role is not eligible for remote or hybrid work arrangements

What else we look for(Preferred):

• Engineering degree

• Medical Device Aerospace or Automotiveindustry experience.

• Knowledge and understanding of FDAs 21 CFR Part 820 ISO13485 ISO9001 and other International Regulatory Standards.

• Experience and/orproficientknowledge ofDesign Controlsandtest method development/validations.

• Experience with statisticaltechniques and toolssuch as Gage R&R Statistical Process Control or Process Capability Studies.

• Ability to conduct effective root cause analysis; driving non-conformance investigations; and assessment of corrective action strategies and effectiveness as appliedthroughCAPAs.

• Knowledge of GD&T and ability to read and interpret drawings.

• Good understanding of process validations(IQ OQ PQ)

• Goodunderstanding of manufacturing processes (i.e. injection molding extrusion machining etc.).

• Good interpersonal skills with the ability to negotiate and influence change.

• Possess the ability to multi-task whilemaintaininghigh attention to detail

• Ability to achieve results in cross-functional team environment and build strong relationships with internal and external customers(suppliers)