Staff Medical Device Autoinjector Engineer
Core
Developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates for autoinjector manufacturing while ensuring regulatory compliance and optimizing processes.
Role type
Staff Medical Device Autoinjector Engineer (Manufacturing/Process)
Builds
Autoinjector devices and manufacturing processes
Domain
Medical Devices / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmaceutical engineering, process improvements, Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), Design History File (DHF) management, Design Master Records (DMRs), root cause analysis, critical process parameters (CPPs) definition, vendor management, regulatory compliance (US/EU), ISO13485, 21CFR820, Lean, Six Sigma
Preferred skills
Autoinjector subject matter expertise, device assembly and tool development, transfer activities from development to operational QC, batch manufacturing qualification
Technologies
None explicitly stated
Responsibilities
Ensure documentation accuracy and regulatory compliance; compile documentation per regulatory requirements; manage post-submission DHF updates; support creation and maintenance of DMRs; identify and implement process improvements; conduct root cause analysis for deviations; participate in FATs and SATs; coordinate with vendors for equipment training; support product feasibility assessments; manage qualification and validation activities for commercial launch
Seniority
Staff, hands-on IC with strategic oversight
