Production Builder I

General Summary

Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing.

Specific Duties and Responsibilities 

• Assemble medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies. * 

• Perform in-process inspection of components and assemblies to verify quality conformance. * 

• Record information on lot history records and perform component accountabilities. * 

• Set-up and operate manufacturing equipment. * 

• Maintain cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program. * 

• Clean supplies and manufacturing equipment and work areas. * 

• Reports causes of process and/or documentation issues and assists in resolution. * 

• Responsible for completion of personal training records. 

• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *  

• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *  

• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *  

• Regular, reliable attendance onsite* 

• Frequent use of microscope* 

• Perform other work-related duties as assigned. 

*Indicates an essential function of the role 

Position Qualifications 

  Minimum education and experience:  

• High School or equivalent with 1+ year clean room assembly experience or manufacturing experience in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience required to perform at this level. 

Additional qualifications:             

• Basic math skills 

• Able to comprehend spoken and written English 

• Effective verbal and written communication skills  

• Able to pay close attention to detail 

• High manual dexterity 

• Basic Working knowledge of cGMP/QSR requirements. 

• Able to use tools such as microscope, soldering iron, tweezer, and other hand-held tools 

Working Conditions  

• Production lab/ Controlled Environment Room (CER)  

• Personnel are gowned and work in a class 10,000 cleanroom    

• Willingness and ability to work on site.   

• Potential exposure to blood-borne pathogens  

• Requires some lifting and moving of up to 25 pounds  

• Must be able to move between buildings and floors.   

• Must be able to remain stationary and use a microscope, cleanroom or laboratory equipment, or other standard office equipment, for an extensive period of time each day.  Will need to use a computer for email, trainings, procedures, etc.   

• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.