Process Engineer - Medical Device Job at Katalyst HealthCares and Life Sciences, Tonawanda, NY

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  • Katalyst HealthCares and Life Sciences
  • Tonawanda, NY

Job Description

Summary :

Key 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.

Education & Experience :

  • 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.

Job Tags

Full time

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