M.S. or B.S. in Engineering (Plastics or Mechanical preferred)
Six Sigma Black Belt is preferred
7+ years of experience in molding, micromolding, and tooling in a manufacturing environment
Experience in design improvements using SolidWorks/CAD
7+ years of experience in technical and product design
Experience in statistical analysis and process control
Recent medical device development experience in FDA regulated and/or ISO 13485 environment
Responsibilities
Collaborate with team members to enhance injection molded products and processes
Develop and implement FDA-compliant validation protocols (IQ/OQ/PQ)
Provide troubleshooting and root cause analysis direction to the team
Apply Lean principles to create effective technical solutions
Participate in cross-functional teams to boost safety, quality, and efficiency
Monitor existing molding processes for continuous improvement
Document process changes through change management practices
Benefits
Innovative work environment at a groundbreaking company in personalized medicine
Exposure to cutting-edge technologies in physics, biomedicine, and nanotechnology
Opportunity for rapid growth and advancement within a global commercial enterprise
Work alongside a talented and recognized team of professionals
Engagement in cross-functional collaboration for diverse project involvement
Full Job Description
Injection Molding Engineer
DUTIES
Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations.
Provide troubleshooting focus and direction for the team with details of root cause analysis.
Utilizes Lean principles to develop creative, thorough and practical technical solutions.
This is a hands-on position where the requirement is to wear many hats where opportunities grow rapidly
Utilize Lean principles to develop creative, thorough and practical technical solutions.
Responsible for debugging, packaging and sterilization.
Document changes to processes and equipment using change management system
Participate in cross functional teams to improve safety, quality, efficiency and overall productivity
Monitor and validate existing injection molding processes and molds to develop and execute continuous improvement opportunities.
Identify risks, technical options value propositions, and champion solutions
QUALIFICATIONS
M.S. or B.S. in Engineering (Plastics or Mechanical preferred)
Six Sigma Black Belt is preferred
7+ years of experience in molding, micromolding, mold flow, mold-making and tooling in manufacturing environment
Experience in design improvements and solid works/CAD
7+ years of experience in diverse technical, materials, manufacturing and product design
Experience in statistical analysis and statistical process control
Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment
Strong written and verbal communication skills as well as documentation and organizational skills
Strong mechanical aptitude
A passion for problem solving and thrive on handling multiple priorities and working in a fast-paced environment
