Process Engineer

Supports manufacturing floor activities and participates in improving existing processes and developing new technologies. Conducts technical investigations of complaints related to the product or manufacturing process. Executes internal and/or external contractor audits (Not applicable to Itero business). Participates in investigations of corrective actions related to customer complaints. Responsible for supporting production and the development of new technologies. Collaborates with R&D in the development of new processes. Participates in process, software, and equipment validations, with support from senior engineers when necessary. Conducts technical investigations of complaints related to the product or manufacturing process (Applies only to Itero business).

Key Responsibilities
- Implement and maintain process control and monitoring systems. Develop inspections and test methods. Conduct test method validations, Gauge R&Rs, depending on feasibility.
- Develop and implement statistical quality control methods and systems to reduce reliance on production inspection.
- Implement continuous improvement projects for processes and products.
- Define and implement cost reduction, scrap reduction, and operations optimization projects.
- Lead internal and cross-functional teams in process development and improvement projects.
- Validate processes, equipment, and software (IQ, OQ, PQ), with support from senior engineers if needed.
- Coordinate risk evaluations in the analysis of new processes and/or products.
- Coordinate meetings and lead corrective and preventive action (CAPA) projects.
- Document, define, measure, and improve current manufacturing processes using statistical quality control techniques and methodologies.
- Ensure that manufacturing processes, techniques, and tools are optimal in terms of quality and productivity.
- Research, develop, and implement new manufacturing processes, methods, and technologies in collaboration with senior process engineers or other resources.
- Integrate and automate manufacturing processes and systems when appropriate and when tangible benefits to operations are identified, with support from senior engineers if necessary.
- Implement and coordinate continuous improvement methodologies and techniques.
- Define process capabilities; monitor and audit/gemba processes; provide technical support to existing operations and new product projects.
- Develop and implement training courses for equipment and processes. Develop support materials as needed.
- Optimize equipment utilization. Determine and implement plant layout and material flow for operations optimization. Specify and implement material handling equipment that optimizes operations and minimizes costs.
- Follow the guidelines in the Internal Work Regulations regarding safety, relationships with other workers, and care of equipment, materials, facilities, and other company-owned resources.
- Monitor the effective achievement of objectives and deadlines assigned to the group.
- Comply with all safety policies, practices, and procedures. Report all hazardous activities to the supervisor and/or Human Resources.
- Participate in team dynamics and efforts to achieve company and departmental goals.
- Other tasks may be assigned.
- May supervise others.

Skills, Knowledge & Expertise

**Desirable education, skills and/or experience**
- Degree in Manufacturing, Mechanical, Electrical, Industrial Engineering, or related field
- 3-5 years of experience in mechanical or process engineering related to the medical industry
- Experience in Six Sigma projects
- Experience in manufacturing operations for medical devices, pharmaceuticals, and/or regulated environments (FDA)
- Preferably knowledgeable in the following areas:

- ISO 13485
- JPAL (Japan Ministry of Health, Labor, and Welfare - Ordinance No. 169, 2004)
- SOR/98-282 (Canadian Medical Device Regulation)
- MDD 93/42/EEC (European Council Directive)
- U.S. Code of Federal Regulations

**Specific language requirements**
- Intermediate English

About Align Technology

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- Country and/or role specific details will be shared with you by your recruiter during the interview process.

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