Process Engineer

Job Summary: Responsible for maintaining manufacturing processes and assisting with ensuring production downtime is minimized and quality is maintained. Develops, standardizes and optimizes 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 executes 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 executes 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 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 well as participating in 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 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.

Position Levels:

Levels

• Level 1: Engineer I - Typically requires no previous professional experience.
• Level 2: Engineer II - Typically requires a Bachelor’s degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience.
• Level 3: Senior Engineer I - Typically requires a minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Level 4: Senior Engineer II - Typically requires a minimum of 8 years of related experience with a Bachelor’s degree; or 6 years and a Master’s degree; or a PhD with 3 years experience; or equivalent experience.
• Level 5: Senior Engineer III - Typically requires a minimum of 12 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 5 years experience; or equivalent experience.
• Level 6: Principal - Typically requires a minimum of 15 years of related experience with a Bachelor’s degree; or 12 years and a Master’s degree; or a PhD with 8 years experience; or equivalent experience.

Education: B.S. in Mechanical Engineering, Electrical Engineering, Manufacturing or Industrial Engineering.

Physical Requirements/Work Environment: This position primarily works in an office 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 (mainly Mexico) travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver’s license is required. 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.