Cambridge, MA, USA | Full Time 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 leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise. We are currently seeking Engineering candidates to add to our growing team. 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