Device Assembly Engineer

4 weeks ago


East Greenbush, New York, United States BioSpace, Inc. Full time
Job Details

Regeneron is currently seeking a highly skilled and experienced Device Assembly Engineer to join our Device Assembly and Packaging team. This role will serve as a combination device and secondary packaging design and development lead for biologic product packaging (clinical and commercial).

The successful candidate will be responsible for driving innovation in the area of device assembly, labelling and packaging by identifying the latest technological advancements and ensuring a creative environment and implementation aligning to business needs. They will also ensure site to site consistency after the processes are optimally transferred, provide floor support during operations of offsite manufacturing, and perform impact assessment for the partner or supplier notifications and develop process maps.

The ideal candidate will have a strong background in device assembly, package development and packaging production process, and experience in the development of regulated medical devices or combination products under Design Control. They will also have knowledge of (21 CFR 820 / ISO and ISO 13485) and be familiar with process validation (IQ, OQ and PQ).

This role might be for you if you are willing and able to travel as required to CMOs or business partners, approximately 25-30% travel (domestic and international). You will also be required to work Monday-Friday, 8:00am-4:30pm and be willing to travel. You must have a BS in Packaging Engineering, Mechanical Engineering or related Engineering field. For various levels, you must have the following:

  • Device Assembly Engineer: 2+ years of related experience
  • Sr. Device Assembly Engineer: 5+ years of related experience


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