Manufacturing Engineer — Medical Devices (GMP, Transfer)

TeamSoft, Inc.; Cambridge (MA); On-site; USD 99,000 - 121,000; Full time

Job summary

TeamSoft, Inc. in Cambridge, MA is seeking a hands-on Manufacturing Engineer to optimize testing jigs, validate methods, and drive design transfer to contract manufacturers within a regulated GMP environment.

The role focuses on executing TMV/IQ/OQ/PQ activities and ensuring tight quality control across R&D and manufacturing operations. You will collaborate with Engineering and Quality to sustain compliant processes and efficient production.

Qualifications

• 2–5 years in medical device manufacturing or R&D engineering within GMP environments.
• Hands-on experience with testing jigs/fixtures and Gage R&R studies.
• Knowledge of injection molding, polymers, catheter/camera assembly, and medical device design.
• Experience with SolidWorks CAD, BOM management, and QMS processes.

Responsibilities

• Evaluate, operate and document mechanical testing fixtures/jigs.
• Perform Gage R&R studies to verify measurement accuracy.
• Support IQ/OQ/PQ activities and design transfer to contract manufacturers.
• Review drawings for DFM compliance and maintain QMS documentation.
• Collaborate with Engineering and Quality to ensure GMP compliance.

Skills

Gage R&R studies

GMP compliance

Design for Manufacturability

Contract manufacturing transfer

Tools

SolidWorks CAD

BOM management

QMS

IQ/OQ/PQ

Job description

TeamSoft, Inc. in Cambridge, MA is seeking a hands-on Manufacturing Engineer to optimize testing jigs, validate methods, and drive design transfer to contract manufacturers within a regulated GMP environment.

The role focuses on executing TMV/IQ/OQ/PQ activities and ensuring tight quality control across R&D and manufacturing operations. You will collaborate with Engineering and Quality to sustain compliant processes and efficient production.