Manufacturing Engineer II
Core
Own process performance for assigned manufacturing lines/cells, driving equipment validation, automation integration, and continuous improvement to meet targets for OEE, yield, and uptime.
Role type
Manufacturing Engineer II (Process & Automation)
Builds
Pipette tips at a high-volume manufacturing center
Domain
Life sciences manufacturing / Injection molding / Automation
Deliverable
production ML models | product features | dashboards & analysis | infrastructure | physical/clinical work
Required skills
PFMEA, Control Plans, DOE, SPC, MSA (GR&R), validation (IQ/OQ/PQ), Lean/Six Sigma toolkit, data analysis, statistical methods
Preferred skills
High-volume production experience, injection molding, clean room, regulated industries, MES/ERP, CMMS, CAD
Technologies
Minitab, Power BI, MES, ERP, CMMS, PLC, HMI, vision systems, sensors, conveyors, pick-and-place
Responsibilities
Serve as central technical owner for manufacturing cell including molding and automation; Maintain technical Standard Work, work instructions, routings, and line balance; Create and maintain PFMEA, Control Plans, Process Flows, and risk-based reaction plans; Plan and execute designed experiments and capability evaluations; Implement Good Documentation Practices (GDP) and support CAPA; Partner with controls engineering to specify, integrate, and sustain automation components; Lead targeted technical Kaizen events; Conduct Job Safety Analysis (JSA) and establish LOTO procedures.
Seniority
Mid-level IC (2-5 years experience)