KEY TASKS & RESPONSIBILITIES:Assist in concept and design layouts of highly automated industrial systems using SOLIDWORKS 2021 to company standardsPerform process validation and product qualification per relevant standards for medical device submissionsPerform IQ, OQ and PQ on the fixtures and equipment used.Complete process qualification of manufacturing line for newest generation productsInvestigate and troubleshoot process deviations and production issues to identify… Show more KEY TASKS & RESPONSIBILITIES:Assist in concept and design layouts of highly automated industrial systems using SOLIDWORKS 2021 to company standardsPerform process validation and product qualification per relevant standards for medical device submissionsPerform IQ, OQ and PQ on the fixtures and equipment used.Complete process qualification of manufacturing line for newest generation productsInvestigate and troubleshoot process deviations and production issues to identify potential product impact using technical and scientific skillsResearch equipment and technologies for use in commercial-size facility and perform comparative analysis to identify cost effective options for scale upResolve manufacturing issues, customer complaints, non-conforming material reports, training, optimization, documentation & equipment issues throughout facilityIntroduce quantitative techniques to identify best known conditions for manufacturing processes and ensure that they are fully complied with (e.g. Designed experiments, Standard Operating Procedures, Process Capability Studies, SPC, Six Sigma)Attain high degree of expertise in process, equipment and operating methods. Able to specify process requirements and new equipment.Participate in Continuous Improvement teams including Operators, Engineering, suppliers and customers. Implement changes needed to improve performance - not just make suggestionsParticipate in new product introductions - define and implement system capability changes to enable manufacture \ sourcing of new productsSupport in day-to-day problem solvingIntroduce and track key performance indicators for waste and process capabilityThe adherence to and continually striving to improve the company’s Health & Safety procedures and maintenance of a safe working environmentEstablish and monitor key and operational metrics to ensure success of initiatives Show less