Location
Tonawanda, New York
Posted
May 16, 2026
Commute
Local Area
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Job Description
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...