"Alerted.org

Cambridge, MA, USA | Full Time

| Health, Dental, 401K

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