Process Engineer– Machining

Position : Process Engineer Machining

Location : Massachusetts

Experience : 5+ years

Employment Type : 12+ Months Contract

Role Overview

We're looking for a Process Engineer with hands-on experience in medical device production and machining processes. This role focuses on supporting both front-end and back-end manufacturing operations, ensuring product quality, smooth workflow, and process documentation within the ERP system.

Key Responsibilities

ERP Data Management

Create and manage Part Numbers (P / Ns) , Bills of Materials (BoMs) , and Methods of Manufacture (MoMs) in the ERP system.

Maintain accurate and up-to-date manufacturing data for all front-end and sample builds.

Front-End Engineering Support

Develop and manage build documentation for sample parts, test parts, and customer test builds .

Collaborate with design and development teams to ensure manufacturability and compliance with medical device standards.

Back-End Support

Draft and update Work Instructions (WIs) to align with production requirements and quality standards.

Guide parts and builds through post-processing (after printing / machining) to completion, ensuring accuracy and timely delivery.

Coordinate communications, emails, and notifications to relevant process or part owners during each stage of production.

Collaboration & Continuous Improvement

Support full-time Manufacturing Engineers with process optimization and troubleshooting.

Identify opportunities for efficiency improvement, cost reduction, and enhanced product consistency.

Participate in design reviews, risk assessments, and validation activities as required.

Required Skills & Experience

Bachelor's degree in Mechanical, Manufacturing, or Industrial Engineering (or equivalent).

5+ years of experience in medical device manufacturing .

Strong background in machining , CNC operations , and manufacturing process development .

Experience with ERP systems (SAP, Oracle, or similar).

Proficiency in reading technical drawings , GD&T , and manufacturing documentation .

Familiarity with FDA / GMP regulations and ISO 13485 standards.

Strong communication and coordination skills across engineering, quality, and production teams.

Preferred Qualifications

Experience with additive manufacturing or post-processing operations .

Knowledge of work instruction development tools or document control systems .

Exposure to prototype / test build environments or customer-specific test programs