Manufacturing Engineer

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

Manufacturing Engineer
Information Technology (IT) Cambridge , Massachusetts Contract Sep 17, 2026

Job Title: Manufacturing Engineer
Client: Direct
Location: Cambridge, MA (02139)—Onsite
Employment Type: Contract to Hire (Will convert to Full Time)
Target Pay Rate: $55/hr
Work Schedule: 7 Hours/Shift

Role Overview

We are seeking a hands-on Manufacturing Engineer to evaluate, optimize, and document in-process and incoming testing jigs, ensuring precise accuracy and repeatability for novel medical device manufacturing. This role is responsible for executing test method validations, supporting equipment qualifications (IQ/OQ/PQ) at contract manufacturing sites, and driving seamless design transfer to contract manufacturers within a regulated GMP environment.

Key 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.

Qualifications & Core Competencies

• Experience: 2–5 years in medical device manufacturing or R&D engineering within regulated GMP environments.
• Technical Skills: Hands-on experience with mechanical testing jigs/fixtures, Gage R&R studies, and disposable manufacturing processes.
• Materials & Design: Working knowledge of injection molding, polymers, catheter/camera assembly, metal processing, and medical device mechanical design.
• Tools & Systems: Proficiency in SolidWorks CAD, BOM management, ECR execution, and Quality Management Systems (QMS).
• Logistics & Quality: Proven track record in lab inventory management, vendor coordination, FMEA, and IQ/OQ/PQ execution.

Ideal Candidate Profile

• Current Title: Manufacturing Engineer / R&D Engineer
• Core Strengths: Strong technical/hands-on orientation, GMP compliance, fixture testing, TMV execution, and contract manufacturing design transfer.
• Target Salary (for C2H/Direct Conversion): $100K – $115K
• Commute Tolerance: Up to 45–60 minutes to Cambridge, MA.

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TeamSoftis anEqualOpportunity Employer. We do not discriminate on the basis of race, color, religion, sex (including pregnancy, sexual orientation, and gender identity), national origin, age, disability, genetic information, and any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace.