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    • Manufacturing Technician - Broadview Heights - Cleveland Diagnostics, Inc.

    Cleveland Diagnostics, Inc.
    Cleveland Diagnostics, Inc. Broadview Heights

    4 days ago

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    Description

    Cleveland Diagnostics Inc. Job Description

    We are seeking a detail-oriented Manufacturing Technician to join our growing team at Cleveland Diagnostics Inc.

    Job Overview:

    • The Manufacturing Technician will be responsible for performing various tasks according to established procedures, including reagent formulation, filling, assembly, packaging, material handling, in-process quality checks, adherence to safety protocols, accurate documentation, and support for continuous improvement initiatives.

    Responsibilities:

    • Formulation, Filling, and Packaging of Class III medical devices according to SOPs, work instructions, and product specifications, ensuring compliance with GMP, FDA, and ISO 13485 standards.
    • Operate and maintain production equipment and perform material staging, line setup, changeovers, and cleaning procedures.
    • Assist in preventive maintenance, equipment calibration support, and basic troubleshooting of equipment.
    • Maintain clean, organized, and compliant work and storage areas, following cleanroom protocols, PPE requirements, and safety guidelines.
    • Support adherence to environmental and hazardous waste handling requirements as outlined by local and federal regulations.
    • Receive, inspect, label, and store raw materials and components, ensuring accurate lot control, FIFO/FEFO usage, and traceability in accordance with inventory procedures.
    • Issue and return materials to/from production using inventory management systems, maintaining real-time inventory accuracy and proper documentation.
    • Conduct physical inventory counts, cycle counts, and material reconciliations of the raw materials and components.
    • Conduct the preparation of finished products for shipment, including packing, labeling, and ensuring that all items are ready for transportation.
    • Coordinate shipping, ensuring the correct materials are shipped on time to meet customer requirements.
    • Assist in the creation, revision, and control of SOPs, work instructions, and training documents to ensure they reflect current processes and regulatory requirements.
    • Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) by completing accurate, timely, and legible documentation (e.g., logbooks, device history records).
    • Assist in identifying, documenting, and escalating non-conformances (NCRs) and supporting root cause investigations and Corrective/Preventive Actions (CAPAs).
    • Support internal and external audits by preparing documentation, maintaining inspection readiness, and answering auditor queries.
    • Contribute to lean manufacturing initiatives, such as 5S, waste reduction, and process optimization, to enhance product quality and reduce downtime.
    • Other duties as assigned.

    Qualifications:

    • Associate degree in Engineering Technology, Life Sciences, Manufacturing, or a related technical field.
    • Minimum of 2 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred).
    • Hands-on experience with FDA, ISO 13485, or GMP-compliant processes is highly desirable.
    • Strong working knowledge of FDA regulations (21 CFR Part 820), ISO 13485, GMP, and GDP standards.
    • Proficiency in reading and following SOPs, technical drawings, and product specifications.
    • Solid problem-solving skills with the ability to identify quality issues and contribute to resolution efforts.
    • Familiarity with ERP or inventory systems for production and material tracking.
    • Strong attention to detail, documentation accuracy, and organizational skills.
    • Ability to work independently and in cross-functional teams in a fast-paced environment.
    • Effective written & verbal communication skills.
    • Proficient computer skills especially with Microsoft applications (Word, Excel, PowerPoint).
    • Ability to manage & prioritize workload effectively.

    Working Conditions:

    • Position is on-site, this is NOT a remote or hybrid position.
    • May be required to stand for long periods of time.
    • Visual acuity to examine specimens and reagents.
    • The ability to distinguish colors.
    • Light lifting may be required; offices reachable by elevator but should be able to climb stairs in case elevator out.
    • May be exposed to hazardous chemicals, biohazards, radioactive materials, etc.
    • Candidate must have ability to maintain punctual daily in-person attendance.
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Manufacturing technician