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