Process Engineer
2 months ago
- Job Description
- SUMMARY To provide direct engineering support to the manufacturing production lines. Ensures that the manufacturing process complies with its specifications and that the product meets qualifications.
- Position duties and responsibilities
- Utilizes Lean and Six Sigma methodologies and analytical problem-solving tools to identify and implement sustaining engineering projects geared to eliminate manufacturing issues, reduce cost, decrease scrap, improve quality, and minimize cycle time.
- Responsible for providing technical expertise and leadership for daily manufacturing operations, ensuring established metrics such as Production, Quality, Scrap, and Cycle Time, are met.
- Identifies and develops action plans to improve process reliability and machine up-time.
- Provides engineering support to product inquiry investigations.
- Conducts assignments encompassing complete projects or portions of major projects.
- Determines methods and techniques to be used or adapts standard methods to meet variations.
- Coordinate work with outside vendors.
- Establishes manufacturing capability to support intra-company product transfers.
- Provides technical expertise to support special projects, pilot operations, product and process improvements, risk management actions, and provides input to develop capital expense forecast and equipment/spare parts budgets to support business needs.
- Supports supplier evaluations for services/products as needed.
- Compliance with safety policies and procedures, including Environmental Management System responsibilities.
- Compliance with Records Management Policies, Records Retention Schedules, company Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records, and third-party vendor if applicable.
- Other responsibilities may be assigned and not all responsibilities listed may be assigned.
- Provides and implements robust corrective actions to quality, safety and ergonomic risk detected in the manufacturing area.
- Management & Supervisory Responsibilities
- May be responsible for directing activities and supervising the completion of tasks assigned to other employees.
- Additional Job Description
- Additional Job Description
- Qualification Requirements:
- Medical device experience including GMP knowledge.
- Knowledge of product and process design and development, materials, standardization, and applied statistics.
- Knowledge of word processing, spreadsheet analysis, data management, project management, presentation graphics, engineering analysis and statistical software such as MiniTab.
- Knowledge of information systems including but not limited to Enterprise Resource
- Planning (ERP), Quality Systems, and Documentation Control Systems such as Windchill.
- Knowledge of project management and cost analysis preferred.
- Education and Experience Requirements:
- B.S. Engineering degree or M.S. Engineering degree.
- Three to five years’ experience in a medical device environment.
- Advance technical training in Finishing preferred.
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