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Process Engineer

Karwell Technologies

Tonawanda, NY

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JOB DETAILS
SKILLS
Continuous Improvement, Corrective Action, Cross-Functional, Equipment Selection, Experiment Design, FDA Requirements, GMP (Good Manufacturing Practices), ISO (International Organization for Standardization), Identify Issues, Lean Manufacturing, Lean Six Sigma, Manufacturing Equipment, Manufacturing/Industrial Processes, Medical Equipment, Medical Protocols, Minitab, Performance Management, Problem Solving Skills, Process Development, Process Engineering, Process Improvement, Process Validation, Regulatory Compliance, Statistics, Support Documentation, Team Player, United States Department of Energy (DOE)
LOCATION
Tonawanda, NY
POSTED
30+ days ago
Responsibilities :
  • Design, develop, and optimize manufacturing processes for medical devices.
  • Execute Design of Experiments (DOE) to improve process performance.
  • Perform process characterization and statistical analysis (e.g., using MINITAB).
  • Collaborate with cross-functional teams including Engineering, Quality, and Operations.
  • Support process documentation for regulatory compliance (FDA, ISO 13485).
  • Identify process improvements and implement corrective actions.
  • Strong knowledge of process engineering principles in a medical device environment.
  • DOE and statistical analysis experience (MINITAB or similar tools).
  • Familiarity with process validation and qualification.
  • Understanding of regulatory standards: FDA, ISO 13485, GMP.
  • Excellent problem-solving, communication, and collaboration skills.

Requirements:

  • Previous experience in process optimization and continuous improvement in a regulated environment.
  • Experience with manufacturing equipment selection, setup, and troubleshooting.
  • Knowledge of lean manufacturing and Six Sigma methods.

About the Company

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Karwell Technologies