Manufacturing Engineer II

4 days ago


North Haven, United States LanceSoft Full time

Must Have:1. Investigation and root cause analysis skills, 2. Technical writing knowledge, 3. Organization and Communication skills, 4. Process Validation and Computer software validation knowledgea Process Development EngineerJOB DESCRIPTIONTop 3 technical skills that are required for this role:Validation and procedure design expe'rience (IQ, OQ, MSA, TMV, PQ, FAT, SAT, SOP)Significant experience in assembly equipment technologies and trouble shooting skill for CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto ChartsStatistical analysis tools knowledge to include Minitab, DOE, process capability, measurement system and confidence interval analysisEducation Required: engineering degree requiredYears' Experience Required: 4+Will the contractor be working 40 hours a week? If not, weekly estimate? YesDoes this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? On-site and < %10 should travel to suppliers domestic.What is your timeline for scheduling interviews? It can start As early as next week 04/08 but depends on applicantsThe Manufacturing Engineer will be working with highly motivated team members and dynamic work environment. This is a great opportunity to interact and work with broad cross-functional groups including different manufacturing sites engineering, quality, share-services, marketing team and extensive business platforms, and suppliers to continuously improve the manufacturability.A Day in the LifeResponsibilities may include the following and other duties may be assigned.Design manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.Design arrangement of machines within plant facilities to ensure most efficient and productive layout.Design sequence of operations and specific procedures for the fabrication of tools and equipment and other functions that affect product performance.Adapt machine or equipment design to factory and production conditions.May incorporate inspection and test requirements into the production plan.Inspect performance of machinery, equipment, and tools to verify their efficiency, and investigate and initiate corrective action of problems and deficiencies to ensure product quality.Develop manufacturing processes that are applicable to statistical process control, and may develop those techniques.Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.Ensure processes and procedures are in compliance with regulations.Experience with FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMPExperience working with statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysisProcess V&V, IQ, OQ, PQ and TMVKnowledge of DFMEA and PFMEA, process mapping and critical to quality reviewsDemonstrated knowledge DFA/DFM, design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&TPTC Creo or SolidworksCAPA, root cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto ChartsExperience or knowledge of engineering drawings and GD&TTraveling maybe required



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