Product Development Manager - Advanced NanoTherapies (ANT)

Title: Product Development Manager - Advanced NanoTherapies

Status: Exempt

Location: Onsite, Cleveland, OH

Reports to: VP of Research and Development

Advanced NanoTherapies (ANT), a portfolio company of T45 Labs, is a clinical-stage medical device company developing next-generation drug-coated balloon (DCB) catheter technologies for the treatment of vascular disease. ANT’s proprietary biodegradable nanoparticle coating platform is designed to improve drug delivery and retention within the vessel wall, with the goal of enhancing treatment outcomes for patients with complex cardiovascular conditions.

Technologies: catheter development, drug-coated balloons (DCB), nanoparticle coatings, cardiovascular devices, design controls, ISO 13485, FDA QSR.

Advanced NanoTherapies is seeking a Product Development Manager to manage development activities for innovative catheter-based medical devices in a fast-moving startup environment.

This role will manage product development efforts from concept through verification, validation, and readiness for clinical studies, working closely with cross-functional teams across engineering, quality, regulatory, and manufacturing.

The ideal candidate combines strong technical understanding of medical device development with the ability to manage projects and drive execution in a highly collaborative environment.

• Manage product development activities for catheter-based medical devices
• Manage design control processes including design planning, risk management, verification, and validation
• Collaborate with cross-functional teams including engineering, quality, regulatory, and manufacturing
• Manage development timelines, milestones, and deliverables
• Work closely with suppliers, external test laboratories, and development partners
• Support prototype development, testing, and design iterations
• Ensure development activities comply with FDA QSR and ISO 13485 design control requirements
• Develop and maintain technical documentation including development plans, protocols, reports, and procedures
• Identify and address technical and program risks
• Support preparation for clinical readiness and regulatory submissions

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, or a related field
• 7 years of product development experience, preferably in a regulated medical device environment
• Demonstrated experience working within FDA and ISO 13485 design control environments
• Strong understanding of verification and validation testing
• Experience managing cross-functional product development project
• Excellent communication and collaboration skills
• Ability to operate effectively in a fast-paced startup environment

• Experience developing Class II or Class III medical devices
• Experience developing catheter-based or cardiovascular medical devices
• Familiarity with drug-device combination products
• Experience working with contract manufacturers and external suppliers
• Experience collaborating with physicians or clinical teams

• Be part of a growing, innovative medical device company developing next-generation cardiovascular therapies
• Work on cutting-edge catheter technologies and nanoparticle drug-delivery platforms
• Contribute directly to devices designed to improve outcomes for patients with vascular disease
• Opportunity to help shape product development in a fast-moving startup environment

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.

This role is based in Cleveland, Ohio.

Advanced NanoTherapies 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. The anticipated salary range for this position is $115,000 - 136,000. 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. Most candidates should expect to receive an offer within the mid-range of the posted range, based on these considerations.

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.

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.

TC.PRE.P5

Salary : $115 - $136