Process Engineer

Job Summary:
The Process Engineer working as part of CooperVision Specialty EyeCare Division at Procornea is responsible for the provision of process engineering and manufacturing support to operations on areas relating to yield and efficiency and leading the daily monitoring of manufacturing metrics in a medical device manufacturing facility operating to ISO 13485. In summary the role is to maintain and improve the efficiency of the process and develop best practices within the production process.

Essential Functions & Accountabilities:
Draft/develop process ideas to reduce costs improve quality.
Perform risk assessments.
Perform optimization tests.
Develop optimize and standardize operating procedures and work instructions for existing improved or new manufacturing processes and equipment.
Assist and/or lead in solving complex problems analyzing possible solutions using standard methodologies procedures experience judgement and precedents.
Develop specifications validation protocols and reports of activities associated with processes and equipment.
Provides technical advice guidance and training to process and operational personnel on any upgraded and/or new process/equipment introduced into manufacturing.
Generate and present to management progress reports related to project activities and process performance.
Document project activities in accordance with internal and global standards.

Knowledge Skills and Abilities:
Knowledge and experience working in a regulated medical device environment to ISO 13485 and/or FDA Code of Federal Regulations (CFR) Title 21 Part 820 preferred.
Knowledge and experience of process design and development equipment automation design development installation and validation.
Knowledge in statistical process control and monitoring. Knowledge and practical experience of the use of Lean Six Sigma tools is highly desired.
Project management skills.
Ability to guide direct and support process manufacturing and operational personnel.
Excellent communication skills interpersonal skills and ability to influence and motivate peers and management.