Senior Scientist - Design Control (Hybrid)
Core
Lead device design control activities for combination product development, commercialization, and lifecycle management to ensure high-quality products and efficient manufacturing.
Role type
Senior Scientist, Device Design Control Lead
Builds
Combination products and device systems
Domain
Medical Devices / Regulatory Compliance
Required skills
Regulatory compliance (ISO 13485), Risk assessment, Statistical analysis, Technical writing, Process development, Strategic planning, Cross-functional collaboration, Supplier management, Data interpretation, Problem-solving
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead device development design controls for assigned projects; Prepare materials for management review and regulatory submissions; Implement device development strategy and design controls; Resolve project obstacles and communicate strategy to stakeholders; Apply regulatory and compliance requirements; Contribute to the development and enhancement of design control processes; Participate in the strategic development of the Device Design Control function.
Seniority
Senior, hands-on IC