Trade.Information

Provide project management and engineering support for the Drug Eluting Stent area. General responsibilities include:

- Responsible for supporting the Drug Eluting Stent manufacturing production area in a clean room environment.
- Develop process improvements; enhance procedures, fixtures, tooling, and equipment.
- Identify and lead value improvement projects to reduce variability, reduce labor content, and streamline production.
- Optimize processes for improved product quality, yield improvements, and cycle time improvements.
- Effectively analyze, develop, and implement corrective actions to resolve product, process, and system issues.
- Ensure proper documentation is completed to meet BSC Quality System requirements. (e.g., Work Instructions, engineering technical reports, validation protocols and reports, FMEA's, equipment specifications, product prints, etc.)
- Coordinate the creation and execution of process validation documentation (IQ, OQ, PQ) for new, complex equipment.
- Efficiently resolve raw material, process, equipment, and training issues on production floor.
- Implement Lean manufacturing concepts to eliminate non-value added activities.
- Provide Manufacturing Engineering expertise to cross-functional departments, as needed.
- Assist and mentor other Engineers and Technicians.

Solutions are imaginative, thorough, practical, and consistent with organization objectives. Works under only general direction. Frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.

Requirements:
B.S. in Mechanical or Chemical Engineering with 5-7 years work experience in Manufacturing related field.

Special Skills/Preferred experience:
Six Sigma methodologies
Lean Manufacturing methodologies
Equipment/Process validation
Project Management/Strong leadership skills to drive cross-functional initiatives
Working knowledge of FDA QSR's and ISO 13485.
Ability and desire to work in a fast-paced, team-based, dynamic organization. Strong written and verbal communication skills.
 

     B.S. in Mechanical or Chemical Engineering