Overview
On Site
Depends on Experience
Contract - W2
Contract - 12 Month(s)
Skills
ivd
medical devices
medical device
Job Details
Process Development Engineer
Onsite Position
Location: Santa Clara, CA
Experience
Minimum 5 years in medical device, IVD, or regulated manufacturing roles.
Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.
Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).
Knowledge, Skills and Abilities
Strong communication, collaboration, and influencing skills across all levels.
Ability to independently manage technical tasks and projects with minimal supervision.
Demonstrated experience implementing in-process controls and CTQ metrics.
Familiarity with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.
Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).
Minimum 5 years in medical device, IVD, or regulated manufacturing roles.
Experience with microfluidics, surface chemistry, reagent formulation, or cartridge production preferred.
Proficiency in DOE, SPC, and statistical tools (e.g., JMP, Minitab).
Prior experience authoring and managing production documentation in ERP systems (e.g., SAP).
Knowledge, Skills and Abilities
Strong communication, collaboration, and influencing skills across all levels.
Ability to independently manage technical tasks and projects with minimal supervision.
Demonstrated experience implementing in-process controls and CTQ metrics.
Familiarity with structured root cause analysis tools: Kepner-Tregoe, 5 Whys, and Fishbone Analysis.
Familiarity with Lean and Six Sigma principles (Green Belt certification preferred).
Bachelor s degree or higher in Engineering (Biomedical, Chemical, Mechanical) or related discipline. Equivalent combinations of education and/or experience are acceptable.
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