Manufacturing Engineer, Stapler Reloads
Core
Manufacturing Engineer supporting sustaining engineering for precision stapling products used in minimally invasive robotic surgery.
Role type
Manufacturing Engineer (Medical Devices)
Builds
Surgical robotic stapling products and manufacturing lines
Domain
Medical Devices / Robotic Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mechanical engineering, manufacturing line setup, IQ/OQ/DQ/PQ validation, continuous improvement (yield/cycle time/cost), DFx input, medical device quality compliance, failure analysis, PFMEA, statistical methods (Cpk, ANOVA, DOE, GR&R), CAD (SolidWorks)
Preferred skills
Complex mechanism manufacturing, packaging equipment, ISO 13485/ISO 9001 environment, data analysis tools (Minitab, Python, SQL, Tableau), Agile lifecycle management
Technologies
SolidWorks, Minitab, Python, SQL, Tableau
Responsibilities
Set up and duplicate manufacturing lines; validate and qualify equipment/processes; implement continuous improvement projects; maintain medical device quality system compliance; perform failure analysis on discrepant components; design and qualify fixtures/tools; analyze manufacturing line risks via PFMEA; create and refine BOMs and work instructions.
Seniority
Mid-level IC (2+ years experience)