Engineer: Injection Molding Engineer

Nanobiosym Inc

  • Cambridge, MA
  • 30+ days ago
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    Skills

    • Biomedicineunmatched
    • Change Managementunmatched
    • Code of Federal Regulationsunmatched
    • Communication Skillsunmatched
    • Continuous Improvementunmatched
    • Cross-Functionalunmatched
    • Debugging Skillsunmatched
    • Documentationunmatched
    • Editingunmatched
    • FDA (Food and Drug Administration)unmatched
    • FDA Requirementsunmatched
    • Fundingunmatched
    • Healthcareunmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Injection Moldingunmatched
    • Machine Toolunmatched
    • Manufacturingunmatched
    • Mechanical Engineeringunmatched
    • Medical Equipmentunmatched
    • Medicineunmatched
    • Molding Processesunmatched
    • Multitaskingunmatched
    • Nanotechnologyunmatched
    • Organizational Skillsunmatched
    • Physicsunmatched
    • Presentation/Verbal Skillsunmatched
    • Problem Solving Skillsunmatched
    • Product Designunmatched
    • Quality Managementunmatched
    • Risk Analysisunmatched
    • Root Cause Analysisunmatched
    • Safety/Work Safetyunmatched
    • Six Sigma Black Beltunmatched
    • Statistical Process Controlunmatched
    • Statisticsunmatched
    • Sterilizationunmatched
    • Technical Deliveryunmatched
    • Technical Writingunmatched
    • Validation Planunmatched
    • Writing Skillsunmatched

    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 Nanobiosyms 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 IQOQPQ 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

    M.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 worksCAD

    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 andor 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

    Numbers & Facts

    LocationCambridge, MA

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