Medical Device jobs in Canada

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

1. Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
2. Develop and implement validation protocols (IQ/OQ/PQ) that comply with FDA regulations.
3. Provide troubleshooting focus and direction for the team with details of root cause analysis.
4. Utilize Lean principles to develop creative, thorough and practical technical solutions.
5. This is a hands-on position where the requirement is to wear many hats where opportunities grow rapidly.
6. Responsible for debugging, packaging and sterilization.
7. Document changes to processes and equipment using change management system.
8. Participate in cross functional teams to improve safety, quality, efficiency and overall productivity.
9. Monitor and validate existing injection molding processes and molds to develop and execute continuous improvement opportunities.
10. Identify risks, technical options value propositions, and champion solutions.

QUALIFICATIONS

1. B.S. in Engineering (Plastics or Mechanical).
2. Six Sigma Black Belt.
3. 7+ years of experience in molding, micromolding, mold flow, mold-making and tooling in a manufacturing environment.
4. Experience in design improvements and solid works/CAD.
5. 7+ years of experience in diverse technical, materials, manufacturing and product design.
6. Experience in statistical analysis and statistical process control.
7. Recent experience with medical device development, in an FDA regulated (21 CFR 820) and/or ISO 13485 environment.
8. Strong written and verbal communication skills as well as documentation and organizational skills.
9. Strong mechanical aptitude.
10. A passion for problem solving and thrive on handling multiple priorities and working in a fast paced environment.