Manufacturing Engineer

Overview

The Manufacturing Engineer is responsible for providing technical support for the day-today manufacturing/production activities in the manufacture of custom, plastic components used in the assemblies of various medical devices.

• Provides process support for extrusion department
• Hands-on position with visibility on the manufacturing floor
• Requires a high level of interaction with the production, product development, and quality teams
• Supports product development activities, continuous improvement, complaint resolution, CAPA investigations and other quality initiatives
• Supports production departments’ manufacturing issues with technical support as the process expert. Uses strong reasoning and problem-solving skills to investigate and analyze complex problems to determine root cause and implement innovative solutions to prevent recurrence
• Supports and drives continuous improvement activities in the manufacturing department to improve operational performance. Leads technical aspect of process validation projects
• Assist product development teams with design for manufacturability requirements on new products. Supports new capital equipment and tooling purchases with appropriate documentation and evaluation
• Manages multiple technically oriented projects through coordinating internal and external resources
• Collaborates on product complaint resolution

• Bachelor's degree in Engineering or related technical field; at least 5 years of experience in Manufacturing Engineering, Production Engineering
• Knowledge of medical device regulations, pertinent standards and guidances
• Knowledge of quality tools and principles
• Experience in project management and managing multiple activities preferred
• Process validation (IQ, OQ, PQ) preferred
• Equipment qualification (IQ, OQ, PQ) preferred
• Fundamental understanding engineering principles
• Extrusion process development / Extrusion Tooling Design
• Mechanical aptitude preferred
• Understanding of ISO 13485:2016 preferred
• CFR, FDA, OSHA, environmental regulations preferred
• Proficiency at using Microsoft Office applications
• Troubleshooting and problem-solving skills
• Equipment / process troubleshooting preferred