Process Engineer

6 days ago


Toronto, Ontario, Canada Intellectt Inc Full time

Role
:
Process Engineer – Product Development (Medical Devices)

Location:
Woodbridge, ON (Onsite)

Duration:
12 months

Role Summary

Client is seeking a Process Engineer – Product Development to support process development, validation, and design transfer for medical devices. The role focuses on manufacturing process optimization while ensuring compliance with ISO 13485 and FDA 21 CFR 820.

Key Responsibilities

  • Develop and optimize processes (molding, assembly, packaging)
  • Support
    NPD activities: prototyping, DOE, pilot builds
  • Execute IQ/OQ/PQ validations
  • Support tooling qualification and scale-up
  • Perform process capability and root-cause analysis
  • Create PFMEA, Control Plans, and process documentation
  • Collaborate with QA, Design, Operations, and suppliers

Requirements

  • Bachelor'
    s in Mechanical, Industrial, or related Engineering
  • 1–5 years of process engineering experience (medical devices preferred)
  • Hands-on experience with validation, DOE, SPC
  • Knowledge of ISO 13485 / ISO 14971

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