Engr 3, Product Development
KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries. Job Description:Job Title: Engr 3, Product Development / GIE EPI Engineer 3Location: 1550 Northwestern Dr, El Paso, TX 79912Duration: 12-month contract (Temp to Perm Possibility)Summary of Position with General Responsibilities:Leads the technical support to new product transfers and/or product development projects.Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.Essential Job Functions:Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/ToolingCoordinates purchase and delivery of Equipment/ToolingCoordinates installation of Equipment/ToolingDevelops and Executes IQ and OQ Protocols and ReportsDevelops and Executes Test Method Validations / Gage R&RGenerates and Issues for Approval SOPs and Manufacturing ProceduresDevelops and Executes Component QualificationsDevelops and Executes PQ and PPQ Protocols and ReportsDevelops Manufacturing Capacity AnalysisDevelops and Executes Process Characterizations / Design of Experiments (DOE)Develops documentation/justification for assigned capital projectsComplies with cGMP's, Quality Standards , and established policies and proceduresExecutes other duties assigned by his supervisor.Basic Qualifications:Bilingual - English and Spanish (oral and written)Technical writing skillsGMP, ISO, EHS and Statistical regulations knowledgeStrong Computer Skills/Knowledge (Word, Excel, PowerPoint)MS Project knowledgeMinitab ProficiencyAdditional Desirable Qualifications Skills and Knowledge:Lean / Six sigma Training/CertificationProject Management Training/CertificationEngineering Board Certification (EIT / PE)Education and/or Experience:Bachelor's degree in engineeringExperience in the Medical Device / Pharmaceutical Industries: Yes5+ years of experience in the following fields:ManufacturingNew Product TransfersProduct / Process DevelopmentJob Functions Experience in the following:Qualification / Validation (IQ/OQ/PQ)Test Method Validation / Gage R&RProcess Characterization / Design of Experiments (DOE)Manufacturing Line Design / Capacity AnalysisEquipment / Tooling DesignEquipment Installation / Preventive Maintenance Procedure GenerationRoot Cause Analysis / InvestigationSOP / Manufacturing Procedures Generation & Change ControlProduct Financials & Supply Chain Structure DesignOEE Integration, Vertical Start up and Zero-loss mindsetAt KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us atBenefits :Free Healthcare InsuranceVision and Dental Insurance401(k) Retirement PlanFree Life InsuranceSick Time OffAchieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like:CertificationsMentorship ProgramReferralsFamily and Wellness benefitsContinuous Growth and Career Development