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Medical Device Production Specialist

2 months ago


Scarborough, Maine, United States Axelon Full time
Job Summary

We are seeking a highly skilled and detail-oriented Medical Device Production Specialist to join our team at Axelon. As a key member of our manufacturing cell, you will be responsible for the production of high-quality cardiovascular medical devices.

Key Responsibilities
  • Assemble and operate various equipment and machinery to produce medical devices, adhering to documented procedures and quality standards.
  • Perform routine work in all production areas with minimal supervision, ensuring quality and efficiency.
  • Conduct visual inspections and precision measurements on components and assemblies to ensure accuracy and quality.
  • Operate computerized test equipment to test units and perform repairs and corrections as needed.
  • Maintain accurate records and documentation to ensure traceability and quality control.
  • Participate in continuous improvement initiatives to enhance production processes and achieve quality and profitability metrics.
Requirements
  • High school diploma or equivalent combination of education and experience.
  • 1+ years' experience in a manufacturing environment, preferably in medical device production.
  • Knowledge of GMP and its application to manufacturing operations.
  • Ability to read, comprehend, and follow English written procedures at a 6th grade level.
  • Good basic math skills and ability to communicate effectively in English.
Preferred Qualifications
  • Demonstrated knowledge and understanding of medical device manufacturing and GMP principles.
  • Prior experience in machine operation and manufacturing cell environments.