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.
· Collaborate with Engineers in developing and implementing Visual Aids and Physical Samples on critical steps of the process to indicate proper acceptance criteria.
· Take charge of training manufacturing staff to release work instructions.
· Manage the execution of Process Validation Protocols or/and Transference Plans and help Engineers generate test reports.
· Maintain and assist Engineers in improving process risk assessments, pFMEA.
· Take the lead and support investigation, disposition, and corrective action of non-conforming materials.
· Identify areas for improvement, maintaining high levels of manufacturing and product quality.
· Maintain and sustain the statistical process controls (SPC) for manufacturing operations.
· Ensure 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 work effectively in cross-functional teams.
Preferred Qualifications:Technical experience working in a 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 at 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 assessments.
Knowledge in developing and executing saving projects through 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.#J-18808-Ljbffr