Job Description

Responsibilities

• Identify improvement opportunities and implement solutions to reduce process variation, enhance productivity, and minimize scrap
• Develop and optimize manufacturing processes through the design and modification of equipment used in fabrication, assembly, and installation
• Provide cross-functional support to R&D, manufacturing, marketing, and customer service, while interfacing with customers and suppliers
• Apply Six Sigma methodologies to determine critical process parameters and establish monitoring tools that support cost reduction initiatives
• Lead projects within a matrix organization, overseeing all phases from planning through execution
• Independently conduct validations and support technicians and engineers in executing IQ, OQ, PQ, and TMV protocols
• Drive continuous improvement initiatives to enhance manufacturing capability
• Mentor and guide junior engineers and technicians in the development of new products and technologies
• Support strategic initiatives, including product line transfers and related activities
• Assist in the design and development of gauges, fixtures, tooling, and manufacturing methods
• Perform design and process FMEAs
• Partner with value stream teams to implement cost reduction and cost avoidance strategies

Qualifications

• Bachelor’s degree in Engineering required, Preferred disciplines: Plastics, Chemical, Biomedical, or Mechanical Engineering, Minimum of 3 years of experience in process development or process improvement within a manufacturing environment
• Experience in medical device or other regulated industries (e.g., ISO, FDA) preferred

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