Senior Technician

Responsibilities

• Design and implement equipment upgrade to improve reliability and increase production output.
• Lead or be an active team member to drive continuous improvement programs to improve equipment performance and reliability, maximize Mean Productive Time Between Failure (MTBF), and Operational Uptime (AOU), and minimize Mean Time To Repair (MTTR).
• Take ownership of the new equipment specification, technical negotiation with vendors, design and documentation review, installation, and qualification testing and documentation.
• Ensure project is on schedule, and at the same time deliver with the highest quality by proactively identifying and correcting capability, reliability, and Maintenance issues early on. Document lessons learned in an efficient manner.
• Develop preventive maintenance procedures to reduce equipment and tooling failures
• Generate and maintain accurate and detailed documentations for equipment installation, maintenance and troubleshooting procedures for reference purposes
• Follow SOP on re-validation of existing equipment, tooling and processes
• Perform Root Cause Analysis and Address CAPA on Manufacturing Non-Conformances
• Support equipment related projects which includes but not limited to:
• Purchasing of new or used equipment, set-up, qualification, and release in production.
• Manage multiple projects in manufacturing environment from maintenance of existing machines to specifying, purchasing, and set up of new equipment.
• Integration of different equipment aspects (software and hardware).
• 
  BS, or MS degree in mechanical engineering, electrical engineering, computer engineering or equivalent
• 7+ years of experience in Equipment Engineering supporting high volume manufacturing.
• Good hands-on systems integration experience, troubleshooting, and start-up and commissioning of equipment into production environment.
• Proficient in Solidworks, Autocad, and GD&T.
• Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
• Working knowledge of lean manufacturing.
• Superior communication skills, (written, verbal and active listening.)
• Highly motivated self-starter, capable of self-management with little to no oversight
• Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. is a plus.

Qualifications

• 7+ years of manufacturing and Equipment Engineering support in a high volume manufacturing, Medical Device or related industry
• Experience with operation of Microvue and inspection programs
• Experience with soldering and electrical repairs
• Proficient in Solidworks, Autocad, and GD&T.
• Experienced in PLC, HMI, motion control, instrumentation, pneumatics, and material handling, including robotics. Allen Bradley, Mitsubishi, Omron, Siemens, Adept or Epson experience is a plus.
• Working knowledge of lean manufacturing.
• Superior communication skills, (written, verbal and active listening.)
• Highly motivated self-starter, capable of self-management with little to no oversight
• Strong interpersonal skills and proven ability to establish effective cross-functional working relationships. Ability to effectively participate on multi-disciplinary teams and projects.
• Creative, self-motivated, flexible to work in a small company environment and assume a wide variety of tasks
• Prior experience with FDA regulations and ISO, cGMP, QMS standards, etc. is a plus.
• Experience with performing strength/strain tests
• Experience with micro-assembly
• Comfortable with using microscopes
• Must be hands-on and be able to perform all aspects of aseptic manufacturing
• Effective verbal and written communication
• Ability to work on flexible schedule
• Comfortable using Microsoft Office