Job Title: Lead Product Development Specialist
About the Role:
* Collaborate with cross-functional teams to manage and execute product development initiatives for acute ischemic stroke products.
* Oversee the entire product lifecycle, including material changes, process enhancements, regulatory submissions, shelf-life studies, sales & marketing requests, and returned product investigations.
Responsibilities:
* Gain in-depth knowledge of current products from a technical perspective: design, materials, performance, manufacturing processes.
* Drive product/process optimization projects in partnership with Supply Chain and Quality.
* Support second supplier and/or technical transfer projects.
* Manage project sub-components as part of a larger project team.
* Mentor and oversee less experienced engineers or technicians.
* Lead regulatory submissions and oversee additional Design Verification/Validation studies required by regional authorities.
* Lead product Shelf-Life studies through Design Verification testing.
* Analyze product complaints and investigate returned devices.
* Support CAPA and Non-Conformance processes.
* Evaluate and scope process changes, material changes, vendor changes.
Key Requirements:
* Demonstrated expertise in product development and lifecycle management.
* Excellent collaboration and leadership skills.
* Able to analyze complex problems and develop effective solutions.
* Familiarity with regulatory requirements and industry standards.