Manufacturing Technician- 2nd Shift

Position Summary

This is a hands-on position supporting the day-to-day operations of a medical manufacturing environment as well as all related equipment and machines. This role is responsible for support and improvement of manufacturing processes.  They will support production, as issues arise in the area. The Technician will be the first line of support within the Engineering group. This role is responsible for identifying and troubleshooting process issues on the production floor by working in conjunction with Assemblers, Production Leads, Production Supervisors, Manufacturing Engineers, and Quality Engineers based on the Value Stream tier support structure. The Technician will conduct validations of new or existing equipment and products. This role will also be responsible for completing preventative maintenance tasks, machine setup and continuous improvement projects. 

Principal Responsibilities

•    Day to Day manufacturing support (i.e., machine changeovers, trouble shooting, tooling inspection/verification, etc.)
•    Hands-on equipment and process troubleshooting; Including but not limited to: braiding, reflow, coiling, bonding, tipping, skiving, and inspection.
•    Follow processes and procedures to independently complete reoccurring preventative maintenance of clean room equipment. 
•    Maintain and update preventative maintenance records utilizing COGZ software.
•    Observe machine/cell condition for signs of wear, broken equipment, leaks, etc.  Repair or communicate to maintenance.
•    Basic repairs of fixtures, tables, workstations, shelving, and other production equipment.
•    Lead continuous improvement projects and identify areas for improvement.
•    Assist with Lean principles implementation (flow, standard work, and 5S).
•    Assist Manufacturing Engineer with product transfers.
•    Conduct product and equipment qualifications, including writing protocols and reports (IQ, OQ, PQ). 
•    Maintain cleanroom production supplies.
•    Manage tooling procurement and ordering replacement or spare parts through outside vendors.
•    Assist in design, build or procurement of new or improved machines, tools, fixtures and material handling equipment and coordinating the implementation.
•    Record/maintain/communicate test results, lab notebooks and detailed reports.
•    Work with Quality Document Control on updating and creating documentation.
•    Execute document changes through Engineering Change Orders and Temporary Change Orders
•    Assist and conduct training as required.
•    Provide input to team to assist with customer complaint investigations and Non-Conformances.
•    Use of standard machine shop equipment, including but not limited to, vertical mill, lathe, band saw, bench grinder, and misc. hand tools.
•    Maintains a clean, organized, and safe work environment.
•    Effectively communicate cross-functionally including Production, Manufacturing Engineering, Quality Engineering and Assemblers.  
 

Education / Experience Requirements

•    High School diploma or GED from an accredited institution, preferred.
•    Associates degree in material science, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Quality Engineering, Manufacturing Technology, or related field, preferred.
•    A minimum of 2 years of combined experience in assembly and in a production support role for Catheter or Catheter subassembly manufacturing, required. 
•    A minimum of 2 years of regulated medical device technician experience, or equivalent, required. 
•    Knowledge and application of electrical skills, including but not limited to use of multimeter, ability to interpret electrical schematics and troubleshooting of electrical circuits.
 

Specialized Skills / Other Requirements

•    Proficient with Windows applications: Word, PowerPoint, Excel, Visio, Outlook.
•    Proficient in reading and writing English and interpret documents such as safety procedures, operating procedures, and equipment manuals. 
•    Excellent communication and interpersonal skills.
•    Strong mechanical and electrical aptitude.
•    Experience with clean room maintenance and environmental controls preferred.
•    Ability to read, interpret and create engineering prints.
•    Experience with 3D modeling software; such as SOLIDWORKS and AutoCAD.
•    Capable of running machine shop tools (drill, mill, lathe, grinder) to make simple fixtures.
•    Exposure and understanding of lean manufacturing and six sigma tools preferred.
•    Experience in SAP or similar MRP/ERP system preferred.
•    The ability to work as a team and collaborate cross functionally. 
•    Team player who can manage multiple priorities.
•    Familiarity with statistical process control and metrology.
•    Consistent lifting: 2 - 20 lbs. necessary/ Max = 50 lbs.
•    Engages in walking, sitting, lifting, bending, carrying, talking, and hearing.
 

Working Conditions / Physical Demands

•    Exposure to high production/output machinery and equipment, and constant noise in the production/plant environment. Noise level in the work environment is usually moderate.