Careers that Change LivesA Day in the LifePrincipalSupplier/ManufacturingQuality Engineer(SQE/MFG)Summary ThePrincipalSupplier/ManufacturingQuality Engineeris responsible for:Driving exceptionalcomponentquality through his/herexpertisein supplier selection strategy, supplier management,componentqualifications.SupportingMedtronicinternalassembly/manufacturing processqualificationandvalidation.This roleassistsnew product development teams and suppliers in providing components that consistently meet specifications, quality and reliability,delivery,and cost requirements. Successrequiresbroad knowledge of new product development and manufacturing methodologies, design control systems and quality management practices.Primary ResponsibilitiesConducts supplierselection, assessments, quality system audits andsupplierpart and process qualification(PPAP).Responsible for thecomponentqualification process,FAI,and manufacturability assessment.Lead design for manufacturability and assembly (DFMA) discussion with Medtronic design team and supply base.Assures supplier compliance to relevant quality and regulatorystandards.Provides feedback to design teamsregardingsuppliers' capabilities, tolerance, specifications,measurement,and testmethodologies.Is a liaison between NPD teams and suppliers on technicaland/or quality issues.Works directly with suppliers to achieve goals including some travel on shortnotice.Assures Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with theSupplier CAPA (SCAPA)process.Co-leadwithR&D Manufacturing Engineers onProcess Failure Mode and Effect Analysis (PFMEA),developing Process Control Plans (PCP) and Process Validations (IQ/OQ/PQ).Is informed about advancement in area of expertise and is knowledgeable about new rules, regulations, andstandards.Required Skills and Knowledge New Product Development ProcessesAbility to work with a supplier on requirements, specifications, process improvements, and capabilitystudies.Background in Six-Sigma, LEAN,FTQ,DFSS and related quality management toolsFamiliar with ISO 9001 or ISO 13485/820 requirementsAbility to resolve complex problems requiring detailed data analysis, calculation, orexperimentation.Expertise/experience in Magnetics and Electrical/Electronics(e.g.PCBA, Flex Circuits, etc.)and/orexpertise/experience in Injection Molding, Machining, Die Cast, Stamping, Extrusion, MIM,etcTechnical abilities in understanding the interaction with componentsand assembly(e.g.tolerance analysis, fit and finish, functionality, etc.).Ability todeterminewhich measurement instrument to use in various situations based on considerations such as the characteristic to be measured, the required accuracy level, and uncertainty.Proficiencyin Minitabor JMPandworking knowledge in statistics (e.g.MSA,Normalilty,Capability, Hypothesis Testing, DOE, etc.).Effective verbal and written communication QualificationsBachelor's degree in electrical, Computer, ElectronicsEngineering,or related field+6years' experienceor AdvancedDegree +4years' experience.Must Have: Minimum RequirementsBachelors degree requiredMinimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experienceNice to HaveExperiencein Production Part Approval Process(PPAP), Process Validations, Design for Manufacturability and Assembly(DFMA), Process Failure Mode and Effect Analysis (PFMEA).Medical Device hardware/software/disposables experience ispreferred.A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.? We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here. This position is eligible for a short-term incentive plan.? Learn more about Medtronic Incentive Plan (MIP) on page 6 here.The provided base salary range is used nationally (except in certain CA locations).?The rate offered is compliant with federal/local regulations and may vary by experience,?certification/education, market conditions, location, etc.About MedtronicTogether, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.Physical Job RequirementsThe physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
