Manufacturing Production Operator (PDM)

Job Description

2nd Shift is 2pm - 10:30pm
The Production Operator will be a critical contributor in a mission that truly represents an once-in-a-lifetime opportunity to join a company that is making significant investments in establishing US manufacturing, expanding internationally, and delivering a consistent cadence of product innovations to the market and investing in its people.

This role is responsible for executing manufacturing, safety and quality processes to produce finished goods including the Personal Diabetes Manager (PDM). Processes will be executed according to approved operating procedures and documentation as appropriate for medical devices, and will prioritize patient safety and product quality.

• By direct involvement in Continuous Improvement and Lean methods this role will influence the work processes and overall metrics including safety, quality, productivity and cost. The role may cross-train into related functions.
• Responsibilities: include but are not limited to: Aligned with the production demand schedule, safely execute the production processes to re-configure mobile devices into dedicated PDMs. Use of test fixtures including nested USB connections, touch screen and keyboard instruction and light pneumatic RF sealed chassis/boxes.
• Highlight any discrepancies in quality, safety or other processes. Leverage the integrated data capture to report the results. Collaborate with direct management, Quality and Engineering to correct any issues.
• Ability to view standard red, green and blue colours on a handheld device in order to accurately test the unit.
• Good understanding of English with the ability to follow both verbal and written instructions.
• Accurately and physically unbox/disassembles, moves, assembles, box and transacts components of light assemblies.
• Works from specifications, work orders, work instructions, drawings, travellers, standard operating procedures (SOPs) and general instructions.
• Verify that the documented procedures used are the current released versions.
• Ensure execution of labelling requirements of transacted inventory material.
• Excellent attention to detail, good organization, and capable of working independently with minimal supervision.
• Maintain training on quality processes and other trainings as assigned.
• Understand regulatory requirements (including FDA 21CFR, ISO 13485, cGMP) as related to the role.
• Notifies Team Leader or Production Supervisor of any discrepancies to ensure that quality standards and safety of operations are maintained at all times.
• Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
• Maintain a clean work environment suitable for medical device manufacturing.
• Physically and systematically moves and records the transaction of production materials to support a continuous production flow.
• Counts, weighs, and records materials transacted via data entry move tickets in a time sensitive environment.
• Performs data entry and cycle count. Reconciles inventory.
• Maintains stocking levels on the manufacturing floor.
• Support or assist in the Receiving, Shipping and Quality functions.
• Perform other duties as assigned.
  
  Education and Experience: Minimum Requirements: High School Diploma / GED
  
  Preferred Skills & Competencies: Minimum 2 years experience in a production environment, preferably in a Medical Device and/or electronics test environment. Basic user understanding of mobile device technology and touchscreens
  Experience with Microsoft Dynamics AX or other ERP Software preferred. Proficient in business environment software applications - MS Office.
  Detail-oriented.
  Physical Requirements: Ability to lift up to 20lbs occasionally, 5-20lbs frequently. Required to reach above shoulder frequently and below waist occasionally.
  
  NOTE: This position requires on-site working (requires on-site office/plant/lab work).