Work Schedule: Monday-Friday, 7:00am-3:30pm with occasional overtime
- Perform physical issuance of components and or raw materials needed for a specific Process Order
- Ensure that the operators follow detailed manufacturing and assembly procedures and verify that Lot History Records are properly documented per GDP.
- Ensure that Operators follow Good Documentation Practices when documenting and reviewing Lot History Records, Inspection Records and Testing Record.
- Responsible for packaging products, assembly of kits, verifies that the products meets Quality release criteria; Ensures that the module or assembly are assembled and packaged according to work instructions or related Standard Operating Procedures
- Operates small hand and power tools to assemble products
- Identifies and reports quality problems and follows reporting procedures as directed by Supervisor
- Able to train and work in cross-functional areas/departments
- Able to understand and interpret 1D/2D drawing and is able to follow the bill of materials as specified in the standard work instructions
- Provide mentorship and work flow guidance to Assembler 1/2/Sr Assemblers as necessary
- Ability to train employees in all areas of the assembly department
- Follow good manufacturing practices per company operating procedures.
- Clean, maintain, and operate automated production equipment per SOP's.
- Clean and organize workbenches before and after shift.
- Ensure that the Production Schedule is adhered to and any issues should be escalated to Supervisor
- Perform other duties as assigned by Management.
- High School Diploma, GED, or equivalent required.
- 5+ years of medical device assembly experience.
- Experience working with hand tools, powers tools, and test equipment and good understanding of basic computer applications.
- Leading a team and Training experience a plus
- Regularly required to stand; walk; use hands to finger, handle, or feel and talk or hear.
- Frequently required to sit; reach with hands and arms and stoop, kneel, crouch, or crawl.
- Must regularly lift and /or move up to 25 pounds, frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds.
- Specific vision abilities required by this job include Peripheral vision and Depth perception.