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