Description / Descripción
The Manufacturing / Facilities Engineering Manager oversees the development and implementation of manufacturing processes to maintain proper product functionality as well as cost efficiency. Ensures the Engineering Team and other manufacturing departments work together cohesively. The Manufacturing Engineering/ Facilities Manager is responsible for the development of equipment to aid in the manufacturing process. Reviews, evaluates and implements engineering changes and specification requirements. Manufacturing Engineering / Facilities Manager provides analysis of equipment inspections and failures, developing repair and replacement on existing plant equipment and distribution systems. Additionally, this Position is responsible for the upkeep and maintenance of the manufacturing facility.
- Manage and assist in the completion of the day-to-day activities involving the maintenance of building / facilities and equipment.
- Provide Engineering support of automated manufacturing production equipment.
- Functions as technical advisor to staff regarding tasks, projects, and operations.
- Provide technical support to Manufacturing.
- As a member of the site management team, create and maintain a high sense of urgency in meeting customer needs
- Work with Operations, Quality and Safety to develop and implement policies and procedures for the engineering work performed in the various departments.
- Participate in site co-op program, designing activities and monitoring performance of students.
- Responsible to initiate Continuous Improvement Initiatives in both the manufacturing processes as well as the facility.
- Ensure utilization of automated processes in manufacturing when appropriate and applicable.
- Support Operations and Quality in Cost reduction and process improvement initiatives.
- Review existing processes for efficacy, and efficiency and implement improvement initiatives.
- Manage activities and budget for manufacturing and process improvement projects as needed.
- Responsible for oversight of Plant Maintenance Department.
- Establish and maintain PM (Preventative Maintenance) process in accordance with ISO 13485.
- Oversee engineering CI (Continuous Improvement) activities at the Plant level
- Responsible for process validation though IQ, OQ, PQ during setup of production cells.
KNOWLEDGE, SKILLS, and ABILITIES
- High level of organizational skill is required.
- Ability to work independently, in a fast paced, high-pressure environment.
- Advanced knowledge of Microsoft Excel, Word, and Outlook.
- Knowledge of LEAN Manufacturing concepts principles.
- Advanced communication and problem-solving skills.
- 4-year college degree (Bachelors) in Engineering, Industrial Engineering, Manufacturing Engineering or equivalent.
- 5+ years experience in product manufacturing.
- Working knowledge of US FDA medical device manufacturing, ISO 13485, cGMP, 21 CFR 820, as well as packaging requirements.