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)
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