Cleanroom Sewing Assembly Tech

Role: Final Assembly Technician I in a medical device manufacturing environment, focusing on sewing, assembling, and inspecting heart valve components in a cleanroom setting. Objectives include ensuring high-quality production, adherence to specifications, and maintaining a safe, compliant workspace. Responsibilities encompass sewing sewing cuffs for Mitrals, Aortics, and Conform_X product lines; inspecting components with microscopes; recording production data; and supporting cleanroom cleanliness and safety protocols. Qualifications: High school diploma or equivalent; preferred experience in manufacturing, inspection, assembly, or FDA/ISO practices; basic computer skills; ability to interpret manufacturing instructions and operate microscopes; availability for standard shifts plus OT and weekends. High-value biopharma specifics include involvement in cardiac medical devices, quality-driven manufacturing, and cleanroom GMP compliance. Collaboration likely with quality, production, and engineering teams, though not explicitly stated. Work setup is in a cleanroom environment with standing and lifting requirements, primarily Monday to Friday with overtime. The role emphasizes precision, quality, and adherence to regulatory standards pertinent to medical device production.