Cambridge, MA, USA | Full Time 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. DUTIES + Coordinate a production and Engineering Team in a variety of manufacturing processes. + Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps. + Develop and assist in the process and product monitoring, including the creation of a validation protocol (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 in a growing organization and an opportunity which will grow rapidly QUALIFICATIONS + MS. or B.S. in Engineering (Plastics or Mechanical preferred) or equivalent experience + Six Sigma Black Belt, a plus + 2+ years of experience in molding, mold-making and tooling in manufacturing environment + 2+ years of experience in diverse technical, materials, manufacturing and product design + 2+ years expiernce with CAD + Understanding of statistical analysis and statistical process control + Electromechanical experience is required + Recent experience with an FDA regulated (21 CFR 820) and/or ISO 13485 environment + Good communication and organization skills