B.S. in Engineering (Plastics or Mechanical preferred)
Six Sigma Black Belt preferred
7+ years in molding, micromolding, and tooling in manufacturing
Proficient in design improvements and SolidWorks/CAD
Experience in statistical analysis and process control
Recent medical device development experience in FDA regulated environment
Strong written, verbal, and organizational skills
Responsibilities
Collaborate with teams to enhance products through various manufacturing steps
Develop validation protocols compliant with FDA regulations
Guide troubleshooting and root cause analysis
Apply Lean principles for innovative technical solutions
Engage in hands-on work with diverse responsibilities
Monitor and validate injection molding processes for continuous improvement
Document process changes using change management systems
Participate in cross-functional efforts to boost safety and productivity
Benefits
Opportunities for rapid career growth
Hands-on role allowing for diverse experience
Involvement in innovative problem-solving initiatives
Participation in cross-functional teams
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
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
