The Production Operator is an Operations team member who specializes in manufacturing of implantable product to precise manufacturing processes with direct supervision.
KEY DUTIES AND RESPONSIBILITIES Works with the operations and quality organization with direct supervision in the production of human use product. Performs assembly of product using small piece parts and equipment such as microscopes, small tools, ovens, cleaning equipment and fixturing with well defined documentation in the controlled environmental area. Maintains a clean and well organized work area in production. Follows standard operating instructions, work instructions and manufacturing processes in compliance with company and regulatory guidelines. Completes detailed production traceability documentation. Understands and utilizes QAD for this activity as required. Performs inventory management activities in production as required. Provides feedback to engineering on build, process, tooling and yield issues in production. Performs other production or assembly tasks as assigned. Requirements Required: High school diploma. Proficient in reading and writing English. Self-motivated, quick learner, and works well in a team environment. Capable of understanding and interfacing with shop floor software programs. Preferred: 1-2 years of experience with assembly of product in a clean room (CAE) production environment. 1-2 years of assembly experience in a medical device company. Experience in assembly of medical implantable product in a clean room (CAE) environment preferred. WORKING CONDITIONS AND REQUIRED PHYSICAL EFFORT 8 hour workday from 7-3:30pm. Controlled Access Environment (CAE). This includes gowning (wearing of hairnets, gloves, special footwear, and cleanroom smock). Occasional scheduled overtime work may be required. Capable of lifting 20 lbs. Manual assembly using small tools and microscopes. May be required to be fully vaccinated against the COVID-19 virus and other diseases. Benefits Company Paid Health & Dental Insurance options. Company contributions to an HSA if enrolled in a high deductible plan. 401(k) with company match. Employee stock purchase plan & stock options. 12 company paid holidays per year + PTO. Paid time off for new parents. Company paid life insurance & disability.
