Manufacturing Technician

Position Overview

As a Manufacturing Technician at Cleveland Diagnostics (Onsite – Cleveland Office), you will report directly to the Director of Manufacturing. Cleveland Diagnostics is a dynamic and innovative company dedicated to developing cutting‐edge diagnostic solutions that improve healthcare. In this role, you will work in a fast‐paced, highly regulated manufacturing environment performing tasks such as reagent formulation, filling, packaging, material handling, quality checks, and supporting continuous improvement initiatives while strictly adhering to FDA cGMP and ISO 13485 standards.

Key Responsibilities

• Formulate, fill, and package Class III medical devices per SOPs, work instructions, and product specifications to ensure compliance with GMP, FDA, and ISO 13485 standards.
• Operate and maintain production equipment; perform material staging, line setup, changeovers, and cleaning procedures.
• Assist in preventive maintenance, equipment calibration, and execute basic equipment troubleshooting.
• Maintain clean, organized, and compliant work areas by following cleanroom protocols, PPE requirements, and safety guidelines.
• Support environmental and hazardous waste handling in compliance with local and federal regulations.
• Inspect, label, and store raw materials and components ensuring accurate lot control, FIFO/FEFO usage, and traceability.
• Manage material issuance and returns using inventory systems, ensuring real-time accuracy and documentation.
• Perform physical and cycle inventory counts as well as material reconciliations.
• Prepare finished products for shipment including packing and labeling while coordinating shipping to meet customer requirements.
• Assist with the creation, revision, and control of SOPs, work instructions, and training documents.
• Adhere to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) by ensuring accurate and timely documentation.
• Identify, document, and escalate non-conformances (NCRs) while supporting root cause investigations and CAPAs.
• Support internal and external audits by preparing necessary documentation and maintaining inspection readiness.
• Contribute to lean manufacturing initiatives such as 5S, waste reduction, and process optimization.
• Perform other duties as assigned.

Required 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 within cross-functional teams in a fast-paced environment.
• Effective written and verbal communication skills.
• Proficient computer skills, particularly with Microsoft Word, Excel, and PowerPoint.
• Ability to manage and prioritize workload effectively.

Benefits & Perks

• 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 the entire family
• No cost for employee coverage for Group Term Life, Short & Long Term Disability
• 4% retirement contribution with Employer match
• Incentive Performance Plan, Stock Option Program, and Commission opportunities (for Sales Account Executives)
• Paid Family Leave Program
• Generous PTO plan and holiday program
• Flexible work schedule and a lucrative employee referral program
• Easy access to our newly built-out office space
• Free coffee, snacks, and other goodies throughout the day
• Compensation: $50,000 - $65,000 per year