Principal Scientist – Device Technical and Engineering Lead (Director Equivalent)
Core
Lead device development strategy and cross-functional teams for biologic/drug/vaccine-device combination products, ensuring robust manufacturing processes and regulatory compliance from concept to launch.
Role type
Principal Scientist – Device Technical and Engineering Lead (Director Equivalent)
Builds
Novel biologic/drug/vaccine-device enabled combination products for inhalation, implantation, and injection routes.
Domain
Biopharmaceuticals and Medical Devices
Deliverable
Production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Biomedical Engineering, Combination Products, Design Controls, Device Development, Finite Element Analysis (FEA), Human Factor Engineering, Injection Moldings, Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Management, Medical Device Quality Systems, Medical Device Regulations, Medical Devices Design, Process Development Engineering, Process Manufacturing, Product Design, Production Process Development
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead cross-functional Device Working Groups to integrate device development with clinical, regulatory, and commercial functions; Lead Device Development Engineering Core teams for design requirements and execution; Represent Device Development on cross-functional teams including Development and Commercialization Teams; Serve as key point-of-contact with external device designers and suppliers; Oversee technical integration of device development activities including engineering design, analysis, testing, design controls, risk management, and validation; Author and review regulatory submissions (INDs, IMPDs, NDAs, BLAs); Lead clinical supplies production for device component manufacture and final assembly; Lead development of Device Development processes and tools; Maintain engagement in design controls and design history file development; Stay current with new device technologies and regulations; Enhance company image through publications, patents, and professional activities.
Seniority
Principal, strategy & mentorship
