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.
