cGMP Medical Device Tech — Product Development & Prototyping

Terrestrial Bio, Inc.; Woburn (MA); Sur place; USD 34 000 - 41 000; Plein temps

Résumé du poste

Terrestrial Bio, Inc. in Allston and Woburn, MA seeks a hands-on manufacturing specialist to operate cGMP device assembly, execute batch records, and perform in-process testing as our MAP platform scales.

You will work with real medical device components in a clean room environment, contributing to design control and prototyping efforts for next-generation combination products, with onsite 5-day workweeks.

Qualifications

• 2+ years experience in a regulated environment (chemical/biotech/medical device).
• High school diploma; associate degree or trade cert preferred.
• Strong lab techniques: mechanical testing, weighing, inspection, measurement, CAD, 3D printing, statistics.

Responsabilités

• Perform cGMP medical device operations per procedures and batch records.
• Operate device assembly and testing equipment (fixtures, testers, laser sensors, controllers)
• Complete batch records, logbooks, tests following Good Documentation Practices
• Run in-process testing: visual, physical and mechanical
• Contribute to root cause analyses and product development investigations
• Review documentation for completeness and regulatory compliance
• Support process and product development: design control, test method development, in vivo/ex vivo experiments
• Follow safety guidelines: PPE, chemical handling, emergency procedures

Connaissances

Lab techniques

3D printing

Statistical analysis

CAD

Dimensional measurement

Mechanical testing

Formation

High school diploma

Associate’s degree

Trade certification

Outils

Dimensional measurement equipment

Laser sensors

Controllers

Mechanical testers

Description du poste

Terrestrial Bio, Inc. in Allston and Woburn, MA seeks a hands-on manufacturing specialist to operate cGMP device assembly, execute batch records, and perform in-process testing as our MAP platform scales.

You will work with real medical device components in a clean room environment, contributing to design control and prototyping efforts for next-generation combination products, with onsite 5-day workweeks.