Engineer: Manufacturing

Job Description

Job Description

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