Manufacturing Engineer

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

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.

TeamSoft is an Equal Opportunity 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, or any other protected status under federal, state, or local law. We are committed to fostering a diverse and inclusive workplace.