Description

The Manufacturing Engineering Technician is responsible for manufacturing line setup/changeovers, manufacturing technical support, preventative maintenance, troubleshooting, repair, and coordination with calibration and facility service providers. Additionally, this role will support and assist assembly, installation, and qualification of equipment and controls as required.

Manufacturing Engineering Technician Duties and Responsibilities

• Perform calibrations and scheduled preventive maintenance on analytical and other laboratory instruments per Metrology procedures as designated by supervisor.
• Follow all Process Instructions (MPI’s and TPI’s), SOP’s, Quality Policy and other related documents.
• Records applicable information on engineering work orders and travelers, ensuring material traceability, and compliance to good manufacturing practices and standard operating procedures.
• Work independently and make sound judgments regarding work methods and tools and provide support across functional areas and sites.
• Test control systems/instruments and assist in validation of new and existing manufacturing facilities
• Assemble, install, calibrate, fix, repair, and modify instrumentation or systems for manufacturing applications as well as electronic, electromechanical, and pneumatic control devices for utility systems which support the manufacturing facilities. May include: temperature; pressure differential room pressures, chart recorders, freezers/refrigerators, HVAC
• Writing validation and maintenance protocols.

Qualifications

Level I: Minimum of 2 years of experience in equipment maintenance, setup, troubleshooting, and repair or Assembly of electrical/control panels, circuits, or equipment with I/O testing.

Level II: 2-4 years of experience in equipment maintenance, setup, troubleshooting, and repair or Assembly of electrical/control panels, circuits, or equipment with I/O testing.

Level III: 5+ years of experience in equipment maintenance, setup, troubleshooting, and repair or Assembly of electrical/control panels, circuits, or equipment with I/O testing.

• Demonstrates a sense of urgency, strong work ethics, and a "can do" attitude.
• Good interpersonal skills; ability to work as an effective team member.
• Proficient in the use of general hand and power tools, instruments and testing apparatus commonly used in maintenance and instrumentation
• Ability to collect and record measurement data on paper forms, or electronic spreadsheets, and the ability to interpret such data.
• Ability to troubleshoot complex process systems
• Attention to detail is critical, especially relating to assembly process and manufacturing paperwork.
• Experience with operating a computer and software, both instrument control and manufacturing systems.
• Strong verbal and written communications skills.
• Proficient in MS Word and Excel.
• Experience with qualification of medical manufacturing EQP
• Vision abilities required by this job include excellent eyesight and good color vision
• Requires a working knowledge of design control to support and assure completion of compliant design control deliverables. Requires a thorough working knowledge of FDA’s QSR (Quality System Regulations) and ISO 13485 standard.
• Experience in the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, SPC, and Root Cause Analysis required.

Working Conditions
Must be available onsite for direct line support during regular shift, with flexibility to work other shifts or past end of shift, as needed to support manufacturing schedule and downtime events.

Physical requirements

• Must be able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.
• Ability to stand, walk, lift, push or pull light weight occasionally 5 - 20 pounds and reach with hands and arms.
• Capable to bend, squat, stretch, and reach when performing assembly work.

Baebies, Inc. is an equal opportunity employer.