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What you’ll do:

• Evaluates, and improves manufacturing methods, utilizing knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards.
• Develops new manufacturing methods using existing or new equipment to ensure repeatability and conformance to customer specifications.
• Develops processes for manufacturing products using Lean, Six Sigma, and/or Statistics based methods and principles for process excellence.
• Monitors and audits the performance of processes and equipment and makes recommendations for continuous improvement.
• Confers with vendors and internal resources to determine product specifications and arrange for purchase and installation of equipment, materials, or parts, and evaluates products according to specifications and quality standards.
• Maintains control of system software’s, control logic program files, mechanical and electrical schematics, drawings and bills of materials and revision histories.
• Document processes and train operators and other personnel.
• Interact with Product Development to ensure manufacturability or minimize the risks associated with new products transferred to the Commercial Business Group.
• Evaluate equipment and processes for repeatability and make improvements as necessary.
• Investigates, recommends, and justifies new technologies, manufacturing methods and equipment to meet competitive business needs and improve efficiencies.
• Provide technical support to various departments in the Company.
• Develop and run protocols including IQ, OQ, and PQ activities as required.
• Create and revise documents such as Preventative Maintenance, Work Instructions, and Internal Specifications.
• Analyze process outputs using statistical methods to ensure stability.
• Interact with suppliers and obtain quotes as necessary.
• Perform cost analysis, provide budgets, and justify capital expenditures on projects.
• Analyzes and plans work force utilization, space requirements, and workflow, and designs layout of equipment and workspace for maximum efficiency.
• Other duties as assigned.

Who you are:

• Bachelor’s degree in engineering or equivalent experience required.
• 1-3 years’ experience in an engineering or similar role within a manufacturing environment
• Demonstrated ability to lead and manage multiple projects with the ability to meet deadlines and within budget.
• Proficient computer skills using MS office, MS Project, and strong spreadsheet skills.
• Strong analytical, organizational, teambuilding and communication skills
• Independent self-starting work habits.
• Lean Manufacturing, Six Sigma, or associated Continuous Improvement methodology training
• Formal project management training.
• Experience with ISO 13485 and FDA guidelines.