Principal Research Scientist II
Core
Provide technical leadership for the development, evaluation, and lifecycle management of medical devices and combination products.
Role type
Principal, hands-on IC device technical lead
Builds
New or improved injection devices and combination products
Domain
Biopharmaceuticals / Medical Devices
Deliverable
product features
Required skills
Device design, combination product development, design controls, verification and validation, risk management, human factors, technical strategy execution, regulatory standards knowledge, mentoring
Preferred skills
Master's degree or PhD, experience leading in regulated environments, product launch success
Technologies
21 CFR 820, ISO 13485
Responsibilities
Develop and execute technical strategy aligned with program priorities; Lead cross-functional collaboration with operations, R&D, quality, regulatory, and manufacturing teams; Provide expertise in device design, design controls, verification and validation, risk management, and human factors; Ensure strong technical planning, early risk assessment, and effective mitigation strategies; Evaluate emerging technologies and regulatory trends; Drive innovation through improved tools and methods; Mentor and influence technical colleagues and project teams; Present technical concepts and study results to varied audiences.
Seniority
Principal, hands-on IC
