Technical Project Manager (Biomedical) - Exton, PA
Core
Provide technical and project leadership for complex development, industrialization, and manufacturing programs within Specialized Biomaterials Manufacturing, leading cross-functional teams from initial definition through commercialization and handoff to routine manufacturing.
Role type
Senior Technical Project Manager (Biomedical Manufacturing)
Builds
Specialized biomaterials products for commercialization
Domain
Biomedical manufacturing and specialized materials
Required skills
Project management, cross-functional team leadership, technical engineering judgment, risk management, budget and financial management, regulatory compliance (ISO 13485, FDA QMSR), technical proposal development, stakeholder management, data-driven decision-making
Preferred skills
Manufacturing expertise, scale-up experience, customer-facing technical consulting
Technologies
ISO 13485, FDA QMSR, Biomedical Quality Management System
Responsibilities
Lead cross-functional project definition, establish scope and technical requirements, develop and manage integrated project plans, provide technical leadership and engineering judgment, lead development of Technical Proposals and SOWs, partner with Commercial and Contracts functions, build technical credibility with customers, promote data-driven technical decision-making, drive cross-functional execution and accountability, establish project governance, own project financial management, ensure Quality and Regulatory requirements integration
Seniority
Senior, hands-on IC
