Process Development Engineer

The Process Development Engineer provides technical and operational support for consumable and cartridge manufacturing, bridging new product implementation with process optimization to ensure compliance, quality, and manufacturing robustness. Responsibilities include process troubleshooting, validation (IQ/OQ/PQ), process characterization, in-process controls (CTQs/IPCs), root cause investigations, statistical analysis (DOE/SPC), and continuous improvement initiatives using Lean Six Sigma. The role requires strong collaboration in a GMP/ISO 13485 regulated environment, authorship of technical documentation (ERP/SAP), and participation in audits, CAPAs, and technology transfer from R&D to operations.

Qualifications:

• Bachelor’s or higher in Biomedical, Chemical, Mechanical Engineering, or related discipline
  

• Minimum 5 years’ experience in medical device, IVD, or regulated manufacturing
  

• Hands-on experience with process validation, technology transfer, and manufacturing support
  

• Proficiency in DOE, SPC, and statistical tools (JMP, Minitab)
  

• Familiarity with GMP, ISO 13485, FDA QSR (21 CFR 820) compliance
  

• Experience with microfluidics, surface chemistry, reagent formulation, cleanroom operations, or automated liquid handling (preferred)
  

• Lean Six Sigma Green Belt certification (preferred)