Overview

Develops manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors. Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout. This position reports directly to the Engineering Manager.

Responsibilities

• Strict adherence to established Plant safety policies and procedures is expected of each employee.
• Understand and comply with all regulatory requirements such as GMP's, EPA, OSHA and associated company policies and procedures.
• Create and maintain a positive work environment through continuous communication and participation in common goals, while striving to improve our products and services to meet or exceed our customer's expectations.
• Use good judgment where decisions are required in the performance of assigned tasks.
• Perform monthly safety audits and maintain a closed loop system on corrective actions. Develop and maintain programs to highlight safety for all employees.
• Responsible for First Responders and overall, First Aid Program
• Perform and install corrective and preventative actions where required.
• Maintain MSDS system with assistance from the Materials Manager and Documentation Specialist.
• Conduct safety training: fire drills and maintain the OSHA 300 log.
• Audit new equipment for safety and develop appropriate PM's.
• Maintain and revise the PM System as needed. Issue schedules. Develop new PM's.
• Monitor Facility & grounds condition and housekeeping. Implement/recommend changes and or improvements.
• Maintain and update computer and telephone systems as required.
• Perform environmental monitoring of chemicals and provide input on water and air as requested by the Quality Manager. Assure proper levels of positive pressure based on weekly readings.
• Assist manufacturing and finance with standard cost system.
• Lead the annual cost reduction program. Chair the cost reduction meeting.
• Develop quotes for development efforts or new products.
• Develop schedules and monitor progress on all technical projects.
• Work with outside vendors as required.
• Perform other administrative duties as required.
• Maintain supplies and equipment for areas of responsibility by writing and issuing purchase orders.
  
  

Requirements

• Previous experience in medical device manufacturing is required.
• Minimum of seven to ten years of engineering supervision or management required.
• The ability to use, repair and maintain machines and tools.
• Ability to create and modify CAD drawings is preferred.
• Aptitude for computer systems and applications a must.
• Must be detail oriented and demonstrate analytical capabilities.
• Working knowledge of extrusion, blow molding and injection molding and other medical manufacturing a plus.
• Previous experience with Project Management preferred.
• Experience with management of chemicals and associated regulations required.
• Familiarity with GMP's, FDA's 21 CFR 820 and ISO 13485
• Associate degree in engineering required; Four-year BS degree in engineering preferred.
• Analyzing various types of data in different formats.
• Independently solving common business problems which occur frequently.
• Sound decision making
• Technical problem solving and troubleshooting.
• Selling ideas, concepts, and plans of action.
  
  

Training

3 years of work experience plus a master's in engineering management degree from an accredited program