Cleveland Diagnostics · 4 hours ago
Manufacturing Technician
Cleveland, Ohio
Full-time
Onsite
Entry, Mid Level
$50K/yr - $65K/yr
2+ years expCleveland Diagnostics is a dynamic and innovative company dedicated to the development of cutting-edge diagnostic solutions. We are seeking a highly motivated and detail-oriented Manufacturing Technician to perform various tasks including reagent formulation, filling, assembly, and quality checks in a regulated manufacturing environment.
BiotechnologyHealth CareHealth DiagnosticsNeuroscience
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
Qualification
Required
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
Benefits
100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage
100% Employer-paid Dental & Vision for entire family
No cost for employee coverage for Group Term Life, Short & Long Term Disability
4% retirement contribution Employer match
Incentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)
Paid Family Leave Program
Generous PTO plan & holiday program
Flexible work schedule & lucrative employee referral program
Easy to get to office location with newly built-out office space
Free coffee, snacks and other goodies all day long
Company
Cleveland Diagnostics
Cleveland Diagnostics is a diagnostics company developing efficacious, affordable diagnostics tests to improve cancer diagnostics.
51-200 employees
Funding
Current Stage
Late StageTotal Funding
$125.4MKey Investors
Novo HoldingsLYFE CapitalGenomic Health
2025-10-20Undisclosed· $14.42M
2024-01-17Private Equity· $75M
2024-01-17Debt Financing
Leadership Team
J
Jim Canfield
Senior Vice President
Erich Heise
Director of Marketing
Recent News
2025-09-01
2025-08-27
Company data provided by crunchbase