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Process Engineer

Company

Karwell Technologies

Location

Tonawanda, New York, United States

Type

Full-time

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, commu...

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