Position Title: Production Assembler
Functional Group: Manufacturing Engineering, Production, and Materials
Reports To: VP of Operations
Employment Status: Full Time, Exempt
PURPOSE OF POSITION:
The Production Assembler will be responsible for assembling high quality medical devices and product packaging according to established manufacturing procedures in a clean room environment.
MAJOR DUTIES AND RESPONSIBILITIES:
- Assemble/rework and package high quality electromechanical/disposable medical devices and tools according to established manufacturing procedures.
- Support material control and management per established procedures and SOP’s.
- Support the development of manufacturing processes and provide feedback to improve production efficiencies.
- Support incoming inspection, finish good inspections and final product release for distribution.
- Perform cleaning of product and clean room environment per established procedures and SOP’s.
- Provide feedback and verification of assembly and testing procedures.
- Perform occasional lifting of up to 30 pounds for inventory and equipment relocation.
- Display working knowledge of the proper use of hand tools, simple power tools, and basic electronics.
- Support development of methods for effective use of in-house test and production fixturing.
- Maintain a clean and organized work area to facilitate manufacturing functions.
- Generate accurate production records on a consistent basis.
- Interpret assembly drawings and perform data entry either written or via computer.
- Support quality assurance with production report review, manufacturing process auditing, and collection ofproduction data for analysis as needed.
- Provide hands on job function training to coworkers as needed.
- Notify the supervisor of any production abnormality or unsafe conditions and practices.
- Perform other duties as requested.
- 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.