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Reference Number:
SSP-HE779
Job Description:
Senior level engineer needed to develop technology for medical device assemblies, providing leadership and direction in design and development of manufacturing processes to enable the introduction of new Vascular Surgery products. Assess process capabilities, prioritize process improvement opportunities, and implement process improvements on complex projects. Evaluate internal and external technologies to solve complex problems. Review and assess new processes for potential patent opportunities. Serves as a subject matter expert on platform and complex projects. Execute functional deliverables associated with the Technology Product Development Processes, Project Management, and Quality Systems. Ensure visibility and closure of process issues. Provides ongoing mentoring and technical guidance to managers, other engineers, technicians, and functional groups.
Experience Level:
5+ Years
Requirements:
BS in Mechanical Engineering, Chemical Engineering or other related technical degree plus a minimum of 7 years of process engineering, manufacturing engineering, product development or other related experience is required. A Masters of Science with minimum 4 years or Ph.D. with minimum of 3 years experience is ideal.
Prior experience in the design and implementation of manufacturing systems for medical products is required.
Experience in leading teams in new process development, commercial scale-up, and process validation in an FDA or other regulated manufacturing environment is preferred.
Prior experience in spray coating, plastic component assembly, and/or experience in textile processing (i.e. knitting, weaving, warping, etc) is helpful.
Must have experience performing various types of statistical analysis and be able to demonstrate expertise and leadership in the use of statistical experimental design and analysis techniques. Experience in utilizing Six Sigma tools and analysis is preferred. Must be able to demonstrate competency in leading others in critical thinking, problem solving and analysis and effective technical project leadership.
Experience with Kepner-Tregoe problem solving and decision-making tools is a plus.
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