Engineering Technician

Description:

Overview

The Engineering Technician is responsible for ensuring compliance with the US and International Quality System requirements. Areas of focus are product change management (Engineering Change Order process), design revision management (Solidworks/CAD/etc), technical file processing (DHF/risk mgmt./reports), and process improvement.

Responsibilities

Engineering Change Management

· Own and manage the Engineering Change Order (ECO) and Engineering Change Request (ECR) processes from initiation through implementation.

· Coordinate with cross-functional teams to review, approve, and implement design changes.

· Track change status, ensure timely completion, and maintain accurate ECO records.

· Evaluate change impacts on product design, manufacturing, cost, and schedule.

Design Updates & CAD Management

· Implement approved design changes and updates within SolidWorks models, assemblies, and drawings.

· Implement design revision updates, BOM changes, Bill of Operation Changes and costing in the ERP.

· Maintain CAD standards, drawing templates, and file structures.

· Ensure drawings and models accurately reflect released product configurations.

· Support engineers with CAD updates, drawing creation, and design documentation.

Revision & Configuration Control

· Maintain engineering revision control for drawings, models, and technical documentation.

· Ensure correct versioning, release status, and traceability of engineering files.

· Manage document lifecycle within the company’s document management or PDM system.

· Audit documentation for accuracy, completeness, and compliance with company procedures.

Engineering Documentation Support

· Prepare, update, and maintain engineering documentation including:

· Bills of Materials (BOMs)

· Assembly instructions

· Technical specifications

· Work instructions

· Project documentation packages

· Support engineering projects by organizing and maintaining project documentation and design records.

· Ensure documentation is properly released and accessible to manufacturing and other stakeholders.

Cross-Functional Collaboration

· Work closely with engineering, manufacturing, quality, and supply chain teams to ensure design changes are implemented effectively.

· Provide documentation support during product development, design reviews, and production releases.

· Assist with continuous improvement of engineering documentation processes and change management workflows.

Requirements:

Required

· B.S. Degree in an Engineering field is required (mechanical/manufacturing/design).

· 3-5 years’ experience in engineering documentation, CAD support, or change management

· Proficiency in SolidWorks (models, assemblies, and drawings)

· Experience in labeling control (ISO 15223, FDA, CE, etc.)

· Understanding of revision control, configuration management, and document control practices.

· Legally authorized to work in the United States.

Preferred

· 3+ years’ experience in regulated medical device industry highly preferred.

· Experience with electronic Product Data Management (PDM/PLM) and design tools such as Solidworks, CAD, Visual Basic, Windchill, SAP, etc.

· Excellent written and verbal communication skills.

· Knowledge of engineering documentation standards (GD&T, drawing standards, etc.)

· Experience with quality inspection processes and equipment

· Knowledge of safety requirements and legal standards