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- 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
