Manufacturing Operator - Advanced Nanotherapies

Title: Manufacturing Operator - Advanced NanoTherapies

Status: Exempt

Location: Onsite, Cleveland, OH

Reports to: Sr. Director, Engineering

Position Summary

Advanced NanoTherapies, a T45 Labs portfolio company, is an exciting, fast paced, start-up company developing nanoparticle formulations and coating for medical devices to treat vascular disease.  We are seeking an energetic and detail-oriented Manufacturing Operator to support the production of our drug-coated balloon catheter products. This role will primarily focus on operating automated robotic coating equipment used to apply precision drug coatings to balloon catheters, along with supporting downstream assembly, inspection, and testing activities. The position is based in a cleanroom manufacturing environment and plays a critical role in producing high-quality medical devices used in interventional cardiology.  Operators will learn the skills necessary to flourish in a regulated manufacturing environment.

Key Responsibilities

• Operate and monitor robotic balloon coating systems, following approved manufacturing procedures and work instructions
• Prepare materials, components, and fixturing required for coating and assembly operations
• Perform in-process inspections and basic measurements to ensure product quality and consistency
• Accurately complete lot history records, logbooks, and other GMP documentation
• Support additional manufacturing activities as needed, including:
• Catheter component assembly
• Balloon pleating/folding and packaging
• Leak testing and functional testing
• Visual inspection and final product preparation
• Maintain a clean, organized, and compliant cleanroom workspace
• Follow all GMP, quality system, and safety requirements
• Escalate equipment issues, process deviations, or quality concerns promptly
• Participate in training, continuous improvement, and process optimization efforts

Required Qualifications

• High school diploma or equivalent
• 1–3 years of hands-on manufacturing experience in a regulated environment (medical device, pharma, biotech, or similar)
• Strong attention to detail and ability to follow written procedures precisely
• Comfort working with mechanical equipment, automation, or laboratory-style processes
• Ability to work in a cleanroom environment (gowning, standing for extended periods, fine motor tasks)
• Basic computer skills for documentation and data entry
• Strong work ethic, reliability, and willingness to learn.

Preferred Qualifications

• Familiarity with GMP, ISO-regulated environments, or cleanroom operations
• Experience with automated or robotic manufacturing equipment
• Background in precision assembly, coating, or inspection processes

Physical & Environmental Requirements

• Ability to wear cleanroom garments for extended periods
• Ability to perform repetitive, fine motor tasks
• Ability to stand or sit for prolonged periods during manufacturing operations
• Ability to lift up to 25 lbs. occasionally

Why Join Advanced NanoTherapies

• Be part of a growing, innovative medical device company
• Work with cutting-edge robotic manufacturing technology
• Contribute directly to life-saving cardiovascular therapies
• Opportunity for training, skill development, and advancement

Eligibility

Candidates must be permanently authorized to work in the United States without the need for current or future visa sponsorship. We are currently unable to sponsor employment visas or permanent residency (PERM) applications.

Location and Compensation

This role is based in Cleveland, Ohio, and is open to candidates living within a reasonable commuting distance of our office. At this time, we are not considering applicants who would need to relocate, either within or outside of Ohio. There is no relocation package available.is committed to fair and equitable pay practices and may also consider additional compensation elements such as bonuses, equity, and benefits as part of the total rewards package.Salary ranges are based on Cleveland area market data. Actual compensation offered may vary depending on factors such as experience, skills, qualifications, and abilities relevant to the role, as well as the geographic location of the individual hired.The anticipated salary range of this position is $20 - $25 hourly based on Cleveland area market data. Actual compensation will vary depending on factors such as years of experience and skills. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.

Equal Opportunity Statement

Advanced NanoTherapies is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Employment decisions are based on qualifications, merit, and business needs. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Third-Party Recruiter Notice

We do not accept unsolicited resumes from staffing agencies or recruiters without a signed agreement in place. Any resumes submitted without such an agreement will be considered the property of Advanced NanoTherapies, and no fees will be paid if the candidate is hired. Agencies interested in submitting candidates may email careers@t45labs.com

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