Plastics Engineer

Responsibilities

• Partner with colleagues and leadership to enhance and refine injection molded and assembled products, as well as the processing across multiple manufacturing stages.
• Create and roll out validation protocols (IQ/OQ/PQ) aligned with FDA requirements.
• Lead troubleshooting efforts and guide the team through detailed root cause analyses.
• Apply Lean methodologies to engineer inventive, comprehensive, and workable technical solutions.
• Serve in a hands-on capacity where versatility is essential and advancement opportunities emerge quickly.
• Leverage Lean principles to design creative, thorough, and pragmatic engineering solutions.
• Oversee debugging, packaging, and sterilization activities.
• Contribute to cross-functional initiatives aimed at elevating safety, quality, efficiency, and total productivity.
• Track and validate current injection molding processes and tooling to identify and implement continuous improvement initiatives.
• Record modifications to processes and equipment through the change management system.
• Pinpoint risks, assess technical alternatives and value propositions, and advocate for optimal solutions.

Requirements

• Master's or Bachelor's degree in Engineering (Plastics or Mechanical disciplines preferred)
• A Six Sigma Black Belt certification is a plus
• A minimum of 7 years working with molding, micro molding, mold flow, mold-making, and tooling in a manufacturing setting
• At least 7 years of hands-on experience spanning various technical areas, materials, manufacturing, and product design
• Current experience in medical device development within an FDA-regulated (21 CFR 820) and/or ISO 13485 environment
• Background in design enhancement and proficiency with SolidWorks/CAD tools
• Working knowledge of statistical analysis and statistical process control
• Excellent written and oral communication abilities, along with strong documentation and organizational skills
• Demonstrated mechanical aptitude
• A genuine enthusiasm for problem-solving, with the ability to juggle competing priorities and excel in a fast-moving workplace