Manufacturing Engineer – Medical Devices (GMP, Onsite)

TeamSoft; Cambridge (MA); On-site; USD 65,000 - 87,000; Full time

Job summary

TeamSoft in Cambridge, MA is seeking a hands-on Manufacturing Engineer to evaluate, optimize, and document in-process and incoming testing jigs, ensuring accuracy and repeatability for novel medical device manufacturing.

You will drive test method development, validation, and transfer to contract manufacturers within a GMP environment, supporting IQ/OQ/PQ activities and design transfer to CM sites.

Qualifications

• 2–5 years in medical device manufacturing or R&D in GMP environments.
• Hands‑on experience with mechanical testing jigs/fixtures and Gage R&R studies.
• Knowledge of injection molding, polymers, catheter/camera assembly, and metal processing.
• Experience with DFM, QMS, and ECR/doc management.

Responsibilities

• Testing & Jigs Optimization: Evaluate, operate, and document mechanical testing fixtures/jigs; conduct Gage R&R studies to verify measurement accuracy and repeatability.
• Validation & Transfer: Execute Test Method Development (TMD) and Test Method Validation (TMV); support IQ/OQ/PQ activities and design transfer to contract manufacturing facilities.
• Prototyping & Materials: Execute testing on disposable catheter and camera prototypes; manage supply chain logistics, inventory flow, and BOM structures for R&D/manufacturing components.
• Quality & DFM Alignment: Review engineering drawings to ensure Design for Manufacturability (DFM) compliance; manage ECRs, process documentation, and evaluation reports in a QMS using FMEA principles.
• Cross-Functional Collaboration: Partner with Engineering and Quality teams to capture design outputs and ensure strict adherence to GMP standards.

Skills

Gage R&R

Mechanical testing fixtures

Vendor coordination

TMV execution

Lab inventory management

Tools

SolidWorks CAD

BOM management

ECR execution

QMS

Job description

TeamSoft in Cambridge, MA is seeking a hands-on Manufacturing Engineer to evaluate, optimize, and document in-process and incoming testing jigs, ensuring accuracy and repeatability for novel medical device manufacturing.

You will drive test method development, validation, and transfer to contract manufacturers within a GMP environment, supporting IQ/OQ/PQ activities and design transfer to CM sites.