Process Engineer

Job Summary: 

Responsible for maintaining manufacturing processes and assisting with ensuring production downtime is minimized and quality is maintained. Develops, standardize and optimize process equipment, tooling specifications and manufacturing documentation such as visual aids, assembly and testing instructions and product acceptance criteria to meet product specifications. Designs fixtures, jigs, pokayoke and manufacturing tooling. Performs process validations; following IQ/OQ/PQ procedures. Completes disposition of materials and components; works with suppliers to reduce quality issues. Develops and execute cost reduction plans and practices continuous improvement by utilizing best practices; such as lean manufacturing methodologies and/or statistical techniques.  

Duties & Responsibilities: 

Becomes process expert of all process and equipment in the production area. 

Creates and maintains process work instructions associated with all manufacturing processes such as manufacturing assembly and in-process acceptance procedures. 

Develop and Implement Visual Aids and Physical Samples on critical steps of the process to indicate proper acceptance criteria. 

Trains manufacturing staff to released work instructions. 

Specifies, procures, installs, and validates manual, semi-automated and fully automated equipment   

Develops and execute Process Validation Protocols or/and Transference Plans and generates test reports.  

Creates and maintains process risk assessments, pFMEA 

Supports investigation, disposition, and corrective action of non-conforming materials 

Establishes statistical process controls (SPC) for manufacturing operations 

Develops and maintains World Class Manufacturing practices to ensure capability for the company’s products 

Develops and implements cost reduction/process improvement programs 

Minimum & Preferred Qualifications and Experience: 

Minimum Qualifications: 

· Experience with optical / electro-mechanical assembly and testing 

· Experience in modern manufacturing principles and techniques 

· Working knowledge of statistical techniques (e.g., DOE, SPC) 

· Experience in process automation, verification and validation 

· Excellent communication skills and technical writing abilities 

· Excellent conceptual, analytical, and problem-solving abilities 

· Excellent computer skills – Solidworks (CSWA), word processing, and spreadsheets 

· Ability to be work effectively in cross-functional teams 

Specialized Engineer: 

A specialized engineer is considered to be one who carries out his activities in critical areas for the company, which requires possessing high technical skills and knowledge in the assigned area (e.g., Molding, SMT, Front End area, etc), as wells to participate on the development of new processes and/or products. 

Preferred Qualifications: 

Technical experience working in high-volume manufacturing environment. 

Experience in application of statistical process controls in a manufacturing environment 

Experience in manual, semi-automated and automation processes, verification and validation 

Hands-on skills with electro-mechanical troubleshooting and diagnostics 

Excellent technical writing abilities 

Excellent conceptual, analytical, and problem-solving abilities. 

Excellent computer skills - CAD, word processing, and spreadsheets. 

Ability to be part of a team and adept in building and leading teams. 

Knowledge and experience in FDA QSR requirements and preferably ISO-13485 requirements. 

Experience with planning and executing process validations and managing process risk assessment 

Knowledge on developing and executing saving projects thought lean manufacturing techniques. 

Good English communication skills, both verbal and written, and the ability to effectively interface with Research and Development, Quality Assurance, and other functional groups in the organization 

Position Levels: