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)
Skills Required
- Bachelor's degree 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 (IQ/OQ/PQ), technology transfer, and manufacturing support
- Proficiency in DOE and SPC statistical methods
- Experience using statistical tools (JMP, Minitab)
- Familiarity with GMP, ISO 13485, and FDA QSR (21 CFR 820) compliance
- Authorship of technical documentation and familiarity with ERP/SAP systems
- Participation in audits, CAPAs, and root cause investigations
- Experience with microfluidics, surface chemistry, reagent formulation, cleanroom operations, or automated liquid handling
- Lean Six Sigma Green Belt certification
What We Do
Dawar Consulting Inc. is a professional services and staff augmentation firm specializing in IT consulting, workforce solutions, and HCM/HRIS services. They provide technology and business consulting, project delivery, and IT support to help clients achieve their strategic goals. With expertise across IT, Engineering, and Finance, they deliver best-in-class workforce solutions and innovative strategies to drive operational efficiency and business success.
