Sr NPI Manufacturing Engineer
Core
Lead development, validation, and continuous improvement of manufacturing processes for precision flexible needles, catheters, and single-use accessory assemblies for advanced bronchoscopic instruments.
Role type
Senior NPI Manufacturing Engineer (Medical Devices)
Builds
Scalable manufacturing processes for next-generation flexible needles, catheters, and accessory assemblies
Domain
Medical device manufacturing (minimally invasive surgical instruments)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process development, laser welding, adhesive bonding, polymer reflow, statistical analysis (Cpk, DOE, ANOVA), root cause analysis (8D, DMAIC), pFMEA, DFM/DFX reviews, Python for data analysis
Preferred skills
ISO 13485, ISO 9001, catheter/needle assembly validation, Agile, SAP, Controlled Environment Rooms (CER)
Technologies
ALM/PLM systems, SAP, Python
Responsibilities
Develop and validate scalable manufacturing processes for needles and accessories; Support joining and forming processes (laser welding, bonding, crimping); Define assembly and inspection methods; Perform statistical analysis and monitor yield trends; Create pFMEAs and mitigate risks; Collaborate with design, clinical, and supplier teams; Lead root cause investigations; Train manufacturing staff
Seniority
Senior, hands-on IC