Product Development Manager - Advanced NanoTherapies (ANT)
About The Position
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. 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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
