Senior Manufacturing Engineer

Responsibilities

• Modify and create PLC’s programs and automatic vision inspection camera systems based on given requirements and specifications
• Review, repair, and redesign legacy code preferred
• Troubleshoot issues with existing company installed systems
• Requirement Reviews - participate in reviews and work with automation outsourcing to ensure proper implementation of features
• Analyze manufacturing processes to identify issues, quality gaps, inefficiencies, and other opportunities to improve efficiency, quality, output, and technology
• Drive process and product investigations
• Recommends and implements solutions to manufacturing problems
• Document new or revised manufacturing processes and procedures, change orders, and equipment specifications
• Own Non-Conformances and CAPAs
• Interpret mechanical design drawings for electrical requirements (e.g. SolidWorks)
• Research supplier products for assembly components
• Power up electrical systems and configure hardware per application specifications

Qualifications

• Minimum Knowledge & Experience required: Bachelor’s degree (Mechanical or Electrical Engineering) or equivalent years of experience; advanced degree a plus.
• Eight (8) to ten (10) years previous manufacturing engineering experience preferred; previous experience within a regulated medical device or pharmaceutical environment strongly preferred.
• Skills & Capabilities: Six sigma green belt or black belt methodology a plus. Extensive knowledge/experience in process and product manufacturing. Excellent understanding of manufacturing, automation, and sustaining engineering concepts. Technically excellence in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials (BOMs).
• Knowledge of PLC to implement changes to the program for automation and commercial robots, vision systems, injection molding hands on preferred, drying, label printing, pouching, packaging, and ultrasonic welding. In-Depth experience with automation development to be able to suggest proper design improvements.
• Excellent technical writing skills. Expertise in writing and performing validations in a GMP and ISO9001 regulated environment. This also includes URS/FAT for new equipment acquisition. Knowledge of statistical sampling and analysis including design of experiments (DOE) design.
• Proficiency in Solidworks. Understanding of Food and Drug Administration (FDA), Good Manufacturing Practices (GMP), ISO 9000 Standards, and Occupational Safety and Health Administration (OSHA) regulations; previous experience participating in regulatory audits preferred.
• Excellent written and verbal communication skills. Excellent equipment failures troubleshooting skills are required. Working knowledge of MS Office; knowledge of statistical software and large enterprise resource planning (ERP) system preferred.
• Excellent communication, organizational, and time management skills; ability to pay close attention to detail. Good leadership ability.

Pay

The annual base salary range for this role is currently $125,000 to $145,000. This is a bonus-eligible position.

Schedule

Able to travel to visit vendors processes.

Benefits

• Medical, dental, and vision insurance
• 401k plan retirement benefits with an employer match
• Paid vacation and sick leave