Manufacturing Engineer 2

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