Lead engineers with entry level to junior level experience in researching new ideas and technologies and establish robust manufacturing & R&D processes.
Ability to work in a hands-on manner with engineers in resolving manufacturing and R&D issues. Work closely with R&D, Quality, and Regulatory in supporting the development of new products and manufacturing processes to achieve a smooth, successful transfer to Manufacturing Engineering and Production for launch. Job duties :
Leads group of individuals of varying technical experience from entry level to junior level on projects of defined scope and diversity.
Directs subordinates toward clear company objectives in an efficient and effective manner.
Collaborates with all departments and other associates within R&D to achieve company objectives and resolve project issues.
Communicates project status and issues in a timely, clear, and appropriate manner to the organization.
Analyzes and / or directs the analysis of research data to assure robust / repeatable manufacturing processes.
Confers with appropriate departments, resources, and / or outside services to prepare process modifications, clarify problems and develop processes.
Plans and / or prepares quality system documentation, specifications, and detailed drawings.
Drafts and executes process validations.
Manages required builds for new product development in a pilot or production setting, including training of operators and coordination with production planning.
Review and develop manufacturing and R&D documentation (MP, Routers, BOM, etc.)
BS Mechanical Engineering or equivalent.
Three to six (3-6) years experience in medical device industry
Experience in Neurointerventional procedures
Computer skills including Word, Excel, Project, and SolidWorks
Good written and oral communication.
Knowledge of raw material and suppliers.
Good problem solving and conflict management skills.
Knowledge of statistical tools including Design of Experiments (DOE) and Cpk for process development characterization and optimization preferred.
Proficiency in Solidworks and fixture design preferred
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