Staff Scientist, Clinical Sciences (m/f/d)
Core
Develop compliant testing protocols and guidelines for biocompatibility, cleaning, disinfection, and sterilization of reusable and single-use medical devices to support regulatory submissions and product development.
Role type
Staff Scientist (Clinical Sciences)
Builds
Sterilization evaluations, biocompatibility evaluations, and reusable device processing evaluations
Domain
Medical Devices / Regulatory Compliance
Required skills
Sterilization validation principles, Biocompatibility testing, Regulatory standards interpretation (FDA, GMP, ISO), Project management, Technical problem solving, Gap assessment, Documentation creation, Cross-functional collaboration, Mentorship, Financial acumen
Preferred skills
AAMI CISS certification, Knowledge of multiple sterilization modalities (irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat), Environmental controlled area qualification
Technologies
Microsoft Office
Responsibilities
Independently develop compliant testing protocols and guidelines, Coordinate project deliverables with cross-functional groups, Interpret and apply international standards, Support technical problems of significant scope, Lead development of quality system procedures, Support regulatory audits, Train junior team members, Participate in corporate quality system workgroups
Seniority
Staff, hands-on IC with mentorship responsibilities