Sr. Manufacturing Engineer

1 week ago


auburn, United States Intellectt Inc Full time

Role: Sr. Manufacturing Engineer

Duration: 1 Year (with possible extensions)

Location: Auburn, NY


Education Requirements

  • Preferred: Bachelor’s degree in Polymer Engineering, Polymer Science, or a related discipline.
  • Alternative: High school diploma with 10+ years of relevant molding experience.


Required Experience

  • Minimum 5+ years (preferably 8+) in engineering and/or operations with expertise in:
  • Plastic Injection Molding: Process development, mold tool design, and troubleshooting.
  • Regulatory Knowledge: Familiarity with cGMP, FDA, and ISO-regulated environments.
  • Technical Skills:
  • Design of Experiments (DOE) for process development.
  • Risk analysis (e.g., FMEA).
  • GD&T and design of metrology fixtures.
  • First Article Inspection (FAI) and process capability data analysis.
  • Project Management: Overseeing procurement, validation, and regulatory compliance for new equipment.
  • Supplier Interaction: Critiquing and providing feedback to tooling manufacturers and suppliers.
  • Metrology: Understanding measurement processes for plastic parts (highly preferred).


Responsibilities

  • Oversee project management for new equipment validation in a third-party manufacturing environment.
  • Ensure compliance with validation and regulatory requirements.
  • Collaborate with suppliers on design, tooling, and FAT qualification activities.
  • Provide feedback on parts and oversee the process from purchase order to product release.
  • Work on complex projects involving problem analysis and competing factors.


Key Skills and Attributes

  • Strong communication, presentation, and documentation skills.
  • Proficiency in engineering and process development methodologies.
  • Aptitude for working independently or in cross-functional teams.
  • Ability to quickly learn and adapt to new systems and processes.
  • Familiarity with instrumentation molding for process control (advantageous).


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