Summary:
The Production Operator is responsible for the daily production and output while utilizing skills and capabilities to build the highest quality products safely within the schedule requirement.
The position reports directly to the Head of Operations
Key Accountabilities:
Sub and Final Part Assembly – 75%
Accountable to complete the production build per specification and in the timeframe required for the Product while meeting the quality requirements.
Work Cell Organization – 10%
Accountable to maintain the 6S Methodology (Sort, Set, Shine, Standardize, Sustain, Safety) in all work cells that are assigned.
Work Instructions – 10%
Accountable to develop and maintain formal instructions, job aids, and materials that will ensure the production efficiency and quality.
Personal Safety and Quality Assurance – 5%
Continuously improve procedures and methods in the functional team to ensure safety/quality with zero injuries and zero quality issues.
Primary Responsibilities:
Sub and Final Part Assembly – 75%
- Ensure that the work cell and work order have all of the necessary parts and supplies prior to beginning the work.
- Determine what work instructions are required to meet the quality and production cycle time requirements for the job.
- Follow work instructions and assemble the parts and assemblies in the required time allocated while meeting the quality standards.
- Perform assembly inspection to ensure the sub/full assembly is completed with zero defects or quality issues.
- Complete work order steps and ensure it is accurate and complete prior to submitting.
- Ensure that work cell is replenished with parts and materials so production cell is prepared for next work order.
- Inform Leads of completion and perform next required work order.
Work Cell Organization – 10%
- Understand and follow the 6S methodology to drive work cell improvements and efficiency.
- Frequently review the work flow to ensure that all obstacles are removed or minimized to optimize efficiency and work quality.
- Remove unnecessary parts, tools and processes that do not effect the quality of production practices.
- Keep the work area organized, labeled and “set” so all materials, parts tools etc. can be accessed easily.
- Clean the work area/cell on a daily basis and or between each work order to ensure equipment does not deteriorate or become damaged.
- Notify Leads of tools or equipment that may become damaged or worn.
- Continuously look to standardize practices and methods to be the most efficient during work order production.
Work Instructions – 10%
- Engage in the development of clear work instructions to ensure that assembly process are clear and accurate.
- Periodically review and make edit suggestions.
- Review all job aids and visual instructions to ensure they are accurate and easy to follow.
Personal Safety and Quality Assurance – 5%
- Ensure that you understand all procedural changes and instructions.
- Ensure that safety protocols and proper protective equipment usage are followed to ensure compliance.
- Attend safety meetings to be proactive to safety incident prevention.
Education / Experience Requirements:
- High school degree, Technical/Vocational school, or equivalent experience in a similar position
- 1-3 years in a commercially regulated medical manufacturing environment. Technical training may be applied in lieu of experience.
- Ability to consistently demonstrate a positive, professional attitude which will support activities that enhance the welfare and morale of fellow employees even during periods of shifting priorities.
- Good verbal skills with the able to read, write and speak in English required
- Ability to take and follow specific direction(s) without deviation regarding production of medical devices required.
- Ability to execute repetitive tasks for extended periods of time with minimal mistakes or errors.
- Experience working within medical device quality systems (cGMP) including Quality System Regulation (QSR) and ISO 13485 preferred
- Good computer skills for data entry preferred.
- Soldering/IPC training and/or experience desired.
- Knowledge of ESD practices desired.
- Experience with Microsoft Office (Word, Excel, Outlook) desired.
- Cleanroom production experience desired.
Physical Demands:
- While performing the duties of this job, the incumbent is regularly required to be independently mobile.
- Periods of prolonged sitting or standing.