Engineer: Injection Molding Engineer

Injection Molding Engineer Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverages advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple prestigious peer-reviewed funding awards, Nanobiosym is expanding its talented team into a global enterprise. We are currently seeking Engineering candidates to join our growing team. DUTIES Collaborate with team members and management to develop and improve injection molded and assembled products and processes through various manufacturing steps. Develop and implement validation protocols (IQ/OQ/PQ) compliant with FDA regulations. Provide troubleshooting guidance with root cause analysis. Utilize Lean principles to develop creative, thorough, and practical technical solutions. This is a hands-on position requiring versatility and rapid growth opportunities. Responsible for debugging, packaging, and sterilization processes. Document process and equipment changes using the change management system. Participate in cross-functional teams to improve safety, quality, efficiency, and productivity. Monitor and validate existing injection molding processes and molds, and develop continuous improvement initiatives. Identify risks, evaluate technical options, and champion solutions. QUALIFICATIONS S. or B.S. in Engineering (Plastics or Mechanical preferred). Six Sigma Black Belt certification is preferred. 7+ years of experience in molding, micromolding, mold flow, mold-making, and tooling in a manufacturing environment. Experience in design improvements and proficiency with SolidWorks/CAD. 7+ years of diverse technical experience in materials, manufacturing, and product design. Experience in statistical analysis and process control. Recent experience with medical device development in FDA (21 CFR 820) and/or ISO 13485 regulated environments. Strong written and verbal communication skills, along with documentation and organizational abilities. Strong mechanical aptitude. A passion for problem-solving and ability to handle multiple priorities in a fast-paced environment.

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