Device Assembly Engineer

2 weeks ago


Greenbush, Maine, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Device Assembly Engineer to join our team at Regeneron. As a key member of our Manufacturing Sciences and Technology (MSAT) team, you will be responsible for the design and development of combination device and secondary packaging for biologic products.

Your primary focus will be on ensuring the quality and consistency of our packaging processes, working closely with cross-functional teams to drive innovation and efficiency. You will also be responsible for technical representation during CMO selection, equipment qualification, and technology transfer activities.

Key Responsibilities:

  • Design and develop combination device and secondary packaging for biologic products
  • Ensure quality and consistency of packaging processes
  • Collaborate with cross-functional teams to drive innovation and efficiency
  • Represent technical expertise during CMO selection, equipment qualification, and technology transfer activities

Requirements:

  • BS in Packaging Engineering, Mechanical Engineering, or related field
  • 2+ years of related experience
  • Strong technical expertise in device assembly, package development, and packaging production processes
  • Experience in regulated medical devices or combination products under Design Control
  • Knowledge of 21 CFR 820, ISO, and ISO 14971
  • Strong project management, interpersonal, and communication skills

What We Offer:

Regeneron is an equal opportunity employer and offers a comprehensive benefits package, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.



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