This Sr. Manufacturing Lead position is responsible for ensuring that work is performed and completed on time in a specific work area. This role will be ensuring that materials and equipment/tools are available to the team to execute and meet the production schedule. This role is responsible for ensuring quality is built in performing fiber bundling, filter potting, filter welding, fitting on assembly units and packaging. This level has the capability to independently perform the job duties, good decision-making skills and can train others. In the absence of any operator, the lead will be filling in for the operator as necessary.

·         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 meet Quality release criteria; Ensures that the module or assembly are assembled and packaged according to work instructions or related Standard Operating Procedures

·         Responsible for leading Tier 1 daily meetings and report to Tier 3/4 meetings occasionally

·         Assist with revising work instructions and creating job aides.

·         Responsible for creating work schedules and delegating tasks to ensure proper workflow

·         Ability to collaborate and communicate with other departments to resolve issues or complete tasks at hand.

·         Ability to use problem solving tools such as RCCM, Fishbone diagram, etc.

·         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 workflow 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.
• 2+ years of Lead Role 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
• Flexible schedule and open to overtime.
• Proficient with Excel and Word.
• Tech savvy
• 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.