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Sr Quality Engineer

3 months ago

Grand Rapids, United States LanceSoft Full time

Must Have:Component Qualification Reportsconducing PPAPsInjection MoldingQualification Protocol WritingNice to Have:contract manufacturersJOB DESCRIPTIONTop 3 technical skills that are required for the role:Component Qualification reportsConducting PPAPsInjection moldingEducation Required: Bachelor's Degree or Master'sYears' Experience Required: 4yrs (Bachelor) 2yrs (Master)Will the contractor be working 40 hours a week? If not, weekly estimate? Yes, 40hrsDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Primarily offsite, with option to be onsite at Grand Rapids site for critical meetings. Primary supplier is also located in Grand Rapids - option for occasional site visits if located in region.What is your timeline for scheduling interviews? Targeting wk of May 20What product line will this person support? Cardiac Surgery Cannula and Revasc devicesThe *** Molding & Capital Tooling Team is seeking a Senior Quality / Molding Engineer to lead injection molding qualification activities at 3rd party (contract manufacturer) molded component suppliers. Position will support tooling replacement projects as a result of ***'s recent acquisition of a manufacturing site in Grand Rapids, MI.Experience:Assist in setting up robust injection molding processes on multi-cavity molds and insert moldingExperienced in the ability to partner and coordinate supplier qualification activities (PPAP, IQ, OQ, PQ, DOE, etc) to meet requirements of the application.Proficient in generating qualification requirements and reports for injection molded componentsUnderstands limits / fits, tolerance stack up analysis. Highly experienced in Geometric Dimensional Tolerancing (GDT) and application for inspection setup and tolerancing allowances of molded componentsUse and understanding of Statistical Tools (Design of Experiments, Measurement System Analysis/Gage R&R, Process Capability and Statistical Process Control)Experience leader of cross functional teams including R&D, Marketing, Manufacturing, Regulatory, Quality, Sourcing and Supply Chain through qualification processesDevelop and maintain strong working relationship with functional groups (R&D, ME, Quality Operations, Supply Chain and Regulatory)History of mentoring team membersSkill & Abilities:Strong organizational skillsAnalytical problem solvingDemonstrated initiative and innovationAbility to transfer the technical knowledge to manufacturing operationsReview/prepare test protocols and reports in order to qualify part and product changesWork remotely across time zonesCollaborate cross functionally with team members (i.e. R&D, Regulatory, Suppliers/Contract Manufacturers, Marketing, Biocompatibility, and Operations)Nice to Have:Experience with contract manufacturersSolid understanding of Plastic Part Design / Injection Molding Guidelines