Engineer, Process
Masimo
- Johor Bahru, Johor
- Permanent
- Full-time
- 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
- · 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
- 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