Job Responsibilities:
Device development and establishing device functional tests
Compile Design History Files for drug-device combination products & Complete device design documentation
Monitor & provide technical support during trials, scale-up, exhibit, and commercial batches.
Develop testing procedures for recent packaging materials.
Prepare and review machine trial protocols, technology transfer documents, and labelling artworks.
Packaging development & Artwork review & management activities for sterile / injection products
Prepare specifications, trade dress, SOPs, study protocols/reports, code creation, bill of material, batch packaging records, and master packaging cards.
Initiate vendor qualification, change controls, and material code creation.
Coordinate with vendors and procurement for drawings, samples, and packaging materials.