injection molding engineer

Nanobiosym is on the cusp of rewriting the rules of personalized medicine, mobile diagnostics, 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
Responsible for the development and execution of injection molding projects, and process validation of new molded products. Collaborates on project teams to develop high quality, high reliability and highly manufacturable injection molding products. Utilizes DRM/COS/Lean principles to develop creative, thorough and practical technical solutions. Develops and implements validation protocols (IQ/OQ/PQ) that comply with FDA regulations. Conducts root cause analysis of product quality issues.

Qualifications
S. or B.S. in Engineering (Plastics or Mechanical preferred) Six Sigma Black Belt, a plus 7+ years of experience in molding, mold-making and tooling in manufacturing environment 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 Good communication and organization skills

Nice-to-have skills

• Root Cause Analysis

• Cambridge, Massachusetts, United States

Work experience

• Electronics Engineering
• Mechanical Engineering

Languages

• English