Manufacturing Engineer (Direct Hire)
Job Requisition: 6344
Description for Manufacturing Engineer:
The Manufacturing Engineer will be responsible for sourcing for machined components, establishing and maintaining all vendor partnerships with contract manufactures, process validations, authoring and maintaining manufacturing assembly processes and procedures, and implementation of cost reduction and continuous quality improvement initiatives.
Responsibilities for Manufacturing Engineer:
- Source and lead the validation of precision machined components
- Source and maintain vendor partnerships with contract manufactures
- Coordination between internal Design Engineering teams and vendors to drive effective communication
- Lead process validation activities for new or altered processes in accordance with FDA and ISO standards.
- Support new product development and line extensions to meet company goals, including vendor and product sourcing, process development, creation of manufacturing documentation, reviewing documentation / prototypes from the Engineering team and suggesting improvements, participating in pre-production builds and ensuring results are communicated back to engineering.
- Produce and revise detailed designs and/or CAD drawings, acting as technical expert on products and processes.
- Participate in cross functional teams for the advancement of projects.
- Represents manufacturing/operations on new product development project teams as needed
- Train production personnel on new and revised processes.
- Work with quality and operations personnel to ensure ISO compliance.
Requirements for Manufacturing Engineer:
- Bachelor of Science degree required in Mechanical, Biomedical, Industrial, or Manufacturing Engineering
- At least 3 years of professional experience working in a process, industrial, or manufacturing engineering capacity within the medical devices industry
- Experience in the sourcing and validation of machined parts including turned and milled components
- Experience coordinating with contract manufactures for ECOs and new product introduction
- Experience with Process Validation / Qualification, PFMEA
- Experience with complex electromechanical assemblies including development of standard work instructions and troubleshooting of devices and processes.
- Strong project management skills set with experience in risk management
- Must be a self-starter, capable of completing complex initiatives with minimal supervision
- Good written and oral communication skills required
- Experience with packaging and validation of sterile, single-use disposable components
- Experience working in within an ISO 13485 /FDA regulated environment
- Working knowledge of AutoCAD and/or SolidWorks
- Experience in a high mix, low volume manufacturing environment
*Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening