Senior Moulding Engineer (Onsite)
Core
Owns scientific molding process development and qualification for thermoplastic, LSR, and over molding programs in medical device manufacturing.
Role type
Senior IC Moulding Engineer (Process Development & Validation)
Builds
Robust manufacturing processes, validation protocols (IQ/OQ/PQ), and automated molding cells for medical devices.
Domain
Medical Device Manufacturing / Thermoplastic & LSR Molding
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (specifically: validated molding processes and manufacturing cells)
Required skills
Scientific molding (decoupled process windows), Materials science (resin/LSR selection), Tooling & DFM review, Metrology & statistics (DOE, Cpk, GR&R), Validation & quality systems (ISO 13485, FDA), Project management, CAD software proficiency, Data analysis tools
Preferred skills
Lights-out manufacturing experience, Robotic automation (Fanuc), Six Sigma Green Belt, PMP certification, RJG Master Molder certification
Technologies
SolidWorks, Minitab, JMP, Fanuc Robots, EOAT
Responsibilities
Develop and validate robust manufacturing processes for thermoplastics and LSR molding; Lead process improvement initiatives to enhance productivity and cycle time; Design experiments and analyze data to optimize process parameters; Ensure all processes meet ISO 13485 and FDA regulations; Serve as technical lead for setting up new manufacturing cells including lights-out automated systems; Mentor Junior Engineers in molding fundamentals.
Seniority
Senior, hands-on IC with mentorship responsibilities