Naderi Engineering, Inc.
Staff Process Development Engineer
Naderi Engineering, Inc., Santa Clara, California, United States
Roche
As a member of the Roche Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives. · Author and maintain Work Instructions and other production-related documentation in compliance with quality standards. · Develop and maintain CTQ-Scorecards to track performance against quality attributes. · Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis). · Partner with cross-functional teams for specification development, process characterization, and material qualification. · Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.
Continuous and Process Improvement: · Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., Collaborate across the Roche network to share and implement best practices. · Quality Mindset: · Ensure compliance with Quality System requirements through document control, change management, and monitoring. · Formal Training/Education · Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Minimum 5 years in medical device, IVD, or regulated manufacturing roles. · Experience working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations · Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces. · SAP).
Ability to independently manage technical tasks and projects with minimal supervision. · Demonstrated ability with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis. · Familiarity with Lean and Six Sigma principles (Green Belt certification preferred). · Working knowledge of FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485 standards.
LEAN/Six Sigma Certification – Green Belt preferred (attainable within 12 months). Travel Requirements Domestic and international travel based on business needs.
As a member of the Roche Sequencing Unit's Manufacturing Sciences and Technology (MSAT) team, the Process Development Engineer provides critical technical and operational support to consumable and cartridge manufacturing operations. This contractor role bridges new product implementation and process optimization to maintain high product quality, improve yields, and enhance manufacturing robustness. Provide hands-on support to troubleshoot manufacturing processes and drive improvement initiatives. · Author and maintain Work Instructions and other production-related documentation in compliance with quality standards. · Develop and maintain CTQ-Scorecards to track performance against quality attributes. · Lead or support root cause investigations using structured methodologies (e.g., Kepner-Tregoe, 5 Whys, Fishbone Analysis). · Partner with cross-functional teams for specification development, process characterization, and material qualification. · Plan and execute Design of Experiments (DOE) and perform statistical analysis using tools such as JMP or Minitab.
Continuous and Process Improvement: · Apply Lean Six Sigma methodologies and maintain up-to-date process risk documentation (e.g., Collaborate across the Roche network to share and implement best practices. · Quality Mindset: · Ensure compliance with Quality System requirements through document control, change management, and monitoring. · Formal Training/Education · Bachelor’s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Minimum 5 years in medical device, IVD, or regulated manufacturing roles. · Experience working in a GMP or ISO 13485 compliant manufacturing environment, with direct involvement in process validation (IQ/OQ/PQ) and technology transfer from R&D to Operations · Biosensor or semiconductor manufacturing, especially processes involving functionalized surfaces. · SAP).
Ability to independently manage technical tasks and projects with minimal supervision. · Demonstrated ability with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis. · Familiarity with Lean and Six Sigma principles (Green Belt certification preferred). · Working knowledge of FDA Quality System Regulation (QSR) 21 CFR 820 and ISO 13485 standards.
LEAN/Six Sigma Certification – Green Belt preferred (attainable within 12 months). Travel Requirements Domestic and international travel based on business needs.