Senior Engineer Confipen Platform and Lifecycle Management
Core
Lead design, development, and lifecycle management for commercial Confipen devices and combination products assembly and packaging lines.
Role type
Senior Process Development Engineer (Medical Device/Pharma)
Builds
Commercial combination product and final drug product assembly and packaging lines
Domain
Biotechnology / Medical Devices / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design of Experiments, Statistical Process Control, Root Cause Analysis, Design Controls, Regulatory Standards (21CFR820, ISO 13485, ISO 14971), CAD/SolidWorks, Risk Management, Project Management
Preferred skills
Medical device commercialization, Drug delivery systems, Mechanical design, Design for Manufacturing/Assembly, Multi-site coordination
Technologies
SolidWorks, CAD, Assembly software
Responsibilities
Lead troubleshooting for assembly, testing, and packaging equipment; Manage project scope, schedule, and budget; Provide authorship and expert technical leadership for regulatory filings; Mentor junior engineers; Lead continuous improvement activities; Interface with Process Development and external partners as a technical SME.
Seniority
Senior, hands-on IC with mentorship
