Duties & Responsibilities:
Understand the process requirement of all process and equipment in the production area.
Responsible for maintaining 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.
Execute Process Validation Protocols and/or Transference Plans and assist Engineers in generating test reports.
Maintain and assist Engineers in improving process risk assessments and pFMEA.
Lead and support investigations, dispositions, and corrective actions 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 and process improvement programs are implemented.
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 the application of statistical process controls in a manufacturing environment.
Experience in manual, semi-automated, and automated 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 of developing and executing savings 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