Assistant Engineer, Process

Job Summary:

• Assistant Engineer will be responsible for maintaining manufacturing processes and assisting with ensuring production downtime is minimized and quality is maintained.
• Assist to 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.
• Involve in designs fixtures, jigs, poka-yoke and manufacturing tooling. Able to performs process validations, following IQ/OQ/PQ procedures.
• Able to lead and comply with Engineers to completes disposition of materials and components; works with suppliers to reduce quality issues.
• Maintaining and execute cost reduction plans and practices continuous improvement by utilizing best practices, such as lean manufacturing methodologies and/or statistical techniques.

Duties & Responsibilities:

• Understand the process requirement of all process and equipment in the production area.
• Responsible to maintain process work instructions associated with all manufacturing processes such as manufacturing assembly and in-process acceptance procedures.
• Collaborating with Engineers in developing and implement Visual Aids and Physical Samples on critical steps of the process to indicate proper acceptance criteria.
• Take charge to trains manufacturing staff to released work instructions.
• Managed to execute Process Validation Protocols or/and Transference Plans and help Engineers to generates test reports.
• Maintains and help Engineers to improve process risk assessments, pFMEA
• Able to take lead and supports investigation, disposition, and corrective action of non-conforming materials
• Responsible in identifying areas for improvement, maintaining high levels of manufacturing and product quality
• Maintaining and sustain the statistical process controls (SPC) for manufacturing operations
• Responsible for ensuring 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, FMEA, 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 – CAD software, word processing, and spreadsheets
• Ability to be work effectively in cross-functional teams

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.
• Good conceptual, analytical, and problem-solving abilities.
• Good 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 is an advantage.
• 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

Education:

Diploma and B.S. in Mechanical Engineering, Electrical Engineering, Manufacturing, Mechatronics or Industrial Engineering

Physical requirements/Work Environment

This position primarily works in an office and Production environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local or international travel is necessary, so requires the ability to operate a motor vehicle, maintain a valid Driver's license and maintain a valid travel passport.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.