Tranzeal Incorporated
Overview
Job Title:
System Engineer Seeking a System Engineer to support manufacturing operations. Role involves process development, troubleshooting, and optimization to ensure high product quality, yield, and compliance. Responsibilities
Provide technical support, troubleshoot issues, and optimize processes. Conduct process characterization, capability studies, and DOE/statistical analysis (JMP/Minitab). Develop work instructions, IPCs, CTQ scorecards, and maintain documentation. Lead root cause investigations (5 Whys, Fishbone, Kepner-Tregoe). Ensure compliance with QSR, ISO13485; support audits, CAPAs, and validations. Qualifications
Bachelor’s in Engineering (Biomedical, Chemical, Mechanical, or related). 5+ years in medical device/IVD/regulatory manufacturing. Experience with process validation, technology transfer, microfluidics, surface chemistry, or cartridge production. Proficiency in DOE, SPC, statistical tools (JMP, Minitab). Knowledge of Lean Six Sigma (Green Belt preferred), GMP/ISO standards, and ERP systems (SAP). Strong collaboration, documentation, and problem-solving skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
IT Services and IT Consulting Medical Equipment Manufacturing
#J-18808-Ljbffr
Job Title:
System Engineer Seeking a System Engineer to support manufacturing operations. Role involves process development, troubleshooting, and optimization to ensure high product quality, yield, and compliance. Responsibilities
Provide technical support, troubleshoot issues, and optimize processes. Conduct process characterization, capability studies, and DOE/statistical analysis (JMP/Minitab). Develop work instructions, IPCs, CTQ scorecards, and maintain documentation. Lead root cause investigations (5 Whys, Fishbone, Kepner-Tregoe). Ensure compliance with QSR, ISO13485; support audits, CAPAs, and validations. Qualifications
Bachelor’s in Engineering (Biomedical, Chemical, Mechanical, or related). 5+ years in medical device/IVD/regulatory manufacturing. Experience with process validation, technology transfer, microfluidics, surface chemistry, or cartridge production. Proficiency in DOE, SPC, statistical tools (JMP, Minitab). Knowledge of Lean Six Sigma (Green Belt preferred), GMP/ISO standards, and ERP systems (SAP). Strong collaboration, documentation, and problem-solving skills. Seniority level
Mid-Senior level Employment type
Contract Job function
Information Technology Industries
IT Services and IT Consulting Medical Equipment Manufacturing
#J-18808-Ljbffr