Manufacturing Engineer

Overview

The Manufacturing Engineer is responsible for providing technical support for the day‑to‑day 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