Primary Responsibilities
• Strategic Innovation Pipeline: Leverage applied biomaterial platforms of medical textiles & polymers with process understanding delivering Customer specifications for implantable or access components and or sub-assemblies.
• Organize in partnership Customers Market Indication and administration trends, with feedback from Commercial Team, development Textile innovation roadmap focused on applied biomaterial platforms & processing capabilities in collaborative third party partnerships driving forward thinking of how to maintain a leadership as well as value position.
• Oversight of Medical Materials: Textile & Polymer Engineering: Lead the technical process scalability of Customer component or sub-assemblies ensuring specification requirements supporting robust manufacturing transition and execution.
• Cross Functional Leadership: Partnership with Commercial, Finance, Operations, and Quality functions ensuring communication and alignment on Product Development Portfolio needs supplying visibility for Organizational planning and execution.
• Regulatory and Quality Governance: All applied biomaterial innovations or process development comply with Regulatory standards: ISO 13485 and Product Design procedure.
• Support Customer Facing team in evaluation of opportunities, technical understanding, and execution of Product Development Portfolio.
• Utilizes software management tools: EPR & PMO tools effectively communicating and managing needs for Product Development Team. .
• Establishes and maintains strong industry relationships.
• Demonstrates budget management experience along with Financial Acumen collaborating with Sales & Finance to manage client expectations regarding timing, price, delivery, and project scope.
• Collaborates with Marketing and the client facing team on technical based marketing campaigns and initiatives.
• Supports key Medtech Industry Conferences and/or technical symposia for the purpose of networking and soliciting new clients and business opportunities.
Other Duties
• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP's, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Performs other job-related responsibilities as assigned.
Qualifications
• Bachelor's degree in engineering is required with a preferred advanced degree (Master's or PhD) in Textile Engineering, Biomedical Engineering, or Polymer Science.
• At least 10-15 + years of progressive experience in product and/or process development with minimum of seven (7) years in leadership role with regulated medical device or applied biomaterials.
• Technical Proficiency and demonstrated subject matter expertise in textile or polymers development, engineering, & manufacturing processes.
• Experience in Stakeholder influence via executive presence in communication of vision & execution plans.
• Proven experience in leading, managing, and development product development/engineering teams within the medical device/implant technologies incorporating applied biomaterials platforms.
• Ability to travel approx. 25% of the time both domestic and internationally supporting business needs.
• Location in Philadelphia, PA or Raliegh, NC to effectively lead teams as well as collaborate with cross functional teams.
