Principal Engineer
Core
Lead product and process development for IV solutions and delivery systems, ensuring patient safety and regulatory compliance.
Role type
Principal Engineer (Medical Device/Pharmaceutical Manufacturing)
Builds
IV solutions, delivery systems, and container-closure systems
Domain
Healthcare / Medical Device Manufacturing
Deliverable
product features
Required skills
Risk management, Validation, Design controls, Change management, Materials science, Regulatory compliance, CAPA implementation, Cross-functional leadership
Preferred skills
Knowledge of nDEHP and nitrosamines, Experience with extractables/leachables studies
Technologies
FDA, GMP, ISO, Container-closure systems
Responsibilities
Lead product and process development initiatives, Perform risk assessments related to materials and manufacturing, Evaluate and implement non-DEHP materials, Drive investigations for nitrosamine risks, Partner with Quality and Regulatory teams, Oversee validation and stability studies, Lead complex change management projects
Seniority
Principal, hands-on IC with strategic leadership
