Engineer: Manufacturing

Job Description

Job Description

Injection Molding EngineerNanobiosym 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.DUTIESCollaborate 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 rapidlyUtilize 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 systemParticipate in cross functional teams to improve safety, quality, efficiency and overall productivityMonitor and validate existing injection molding processes and molds to develop and execute continuous improvement opportunities.Identify risks, technical options value propositions, and champion solutions QUALIFICATIONSS. 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/CAD7+ years of experience in diverse technical, materials, manufacturing and product designExperience in statistical analysis and statistical process controlRecent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environmentStrong written and verbal communication skills as well as documentation and organizational skillsStrong mechanical aptitudeA passion for problem solving and thrive on handling multiple priorities and working in a fast paced environment

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