Senior Process Engineer
Core
Provide technical leadership for internal sterilization processing, specifically ethylene oxide (EtO) processes, ensuring quality and regulatory compliance.
Role type
Senior IC process engineer (sterilization)
Builds
Sterilization processes for medical devices
Domain
Medical device manufacturing + sterilization engineering
Required skills
EtO sterilization expertise, process validation, root cause analysis, statistical methods, regulatory compliance (FDA/ISO/EN), continuous improvement, technical documentation
Preferred skills
None stated
Technologies
None stated
Responsibilities
Lead complex technical initiatives for manufacturing support, process development, validation, and continuous improvement; Analyze complaint trends and lead investigations of nonconformances; Design, execute, and analyze complex experiments using statistical methods; Author and approve validation protocols and reports; Interpret and apply regulatory requirements to ensure process compliance.
Seniority
Senior, hands-on IC