The Process Sustaining engineer is responsible for supporting production activities in the medical device industry, including yield improvement initiatives, continuous improvement activities, assembly procedure development and process and system validations. Additional responsibilities might include the transfer of new products and processes into manufacturing, process development, process risk analysis, design reviews, input on design for manufacturing, modeling and implementation of business workflows into Camstar MES.
Support and lead continuous improvement activities and yield improvement initiatives.
Project lead in cost savings, support troubleshooting and product line transfers.
Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
Ensures processes and procedures are in compliance with regulations.
Lead the development and coordinate the execution of process characterization and validation plans.
Develop and implement production processes.
Support production on root cause and develop solutions.
Write and execute process and system validations.
Write technical reports.
Develop tooling and fixtures to support production.
May evaluate new and existing processes for implementation into Camstar MES.
May support modeling workflows and maintaining existing MES workflows.
May support IT electronic workflow team to maintain ERP touch-point data migration and periodic updates.
Travelling Requirement Approx. 10%
Minimum Bachelor's Degree in appropriate engineering field of study or equivalent work experience
Master’s degree desirable
1+ years of engineering / manufacturing experience
Class 3 Medical Device Experience
Strong interpersonal skills including the ability to lead up, across and down multiple business and technology organizations
Proven ability to work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence
Demonstrated communication skills (both written and oral with technical and non-technical staff)
Self-motivated, decisive, with the ability to adapt to change and competing demands
Ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
Proven ability to work in an ambiguous environment and collaborate across multiple areas in order to achieve a common business objective
Familiarity with processes such as FMEA, CAPA and DFM
Good overall theoretical knowledge of mechanical engineering.
Six Sigma Black Belt certification
Continuous improvement experience (Kaizen, Gemba, Daily Management, etc.)
Language(s) / Level English proficiency
Proficient in Microsoft Project, Word, Excel, PPP, Outlook & PLM
Experience with CAD and programming language.