Job Description

Job Title: Process Development Engineer

Job Description

We are seeking a highly motivated Process Development Engineer to lead and support catheter development initiatives within our contract manufacturing operations. This role is critical to driving process innovation, equipment validation, and product quality in compliance with ISO standards.

Responsibilities

  • Lead process development activities for catheter manufacturing, including prototyping, scale-up, and transfer to production.
  • Conduct IQ/OQ/PQ validations for manufacturing equipment and ensure compliance with regulatory standards.
  • Develop and validate test methods to ensure product performance and reliability.
  • Perform process characterizations using statistical tools and methodologies.
  • Utilize Minitab for data analysis, DOE, SPC, and capability studies.
  • Collaborate with cross-functional teams to optimize manufacturing processes and improve y...

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