Bachelor’s or Master’s degree in Engineering (Plastics or Mechanical preferred)
At least 5 years of experience in molding high-precision parts in a manufacturing setting
Solid background in resin processing and mold development
Proven expertise in viscosity analysis, ultrasonic, and electric contact welding
Experience with statistical process control and analysis methodologies
Exposure to ISO 13485 regulated environments
Six Sigma Black Belt and Master Molder certification are advantageous
Responsibilities
Coordinate production and engineering teams across various manufacturing processes
Collaborate to develop and enhance injection molded and assembled products
Develop and implement validation protocols (IQ, OQ, PQ) in compliance with FDA standards
Lead troubleshooting initiatives and perform detailed root cause analysis
Apply DOE/DRM/COS/Lean principles and statistical process control to solve technical challenges
Engage directly in hands-on process and product development within a rapidly evolving organization
Benefits
Join a dynamic company on the cutting edge of personalized medicine, nanotechnology, and healthcare
Experience rapid career growth in a hands-on, fast-growing organization
Work under leadership with prestigious credentials and award-winning industry recognition
Full Job Description
DUTIES
Injection Molding Experience Required
Coordinate a production and Engineering Team in a variety of manufacturing processes.
Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations.
Utilizes DOE/DRM/COS/Lean principles and statistical process control to develop creative, thorough and practical technical solutions.
Provide troubleshooting focus and direction for the team with details of root cause analysis.
This is a hands-on position in a growing organization and an opportunity which will grow rapidly
QUALIFICATIONS
MS. or B.S. in Engineering (Plastics or Mechanical preferred)
Six Sigma Black Belt, a plus
5 years of experience in molding highly critical dimensional parts in manufacturing environment
5 years of experience in resins, and scientific mold process development
Demonstrated experience with viscosity analysis, ultrasonic and electric contact welding
Experience in statistical analysis and statistical process control
