Senior Medical Device Manufacturing Specialist

5 days ago

Melbourne, Victoria, Australia beBeeManufacturing Full time $130,000 - $155,000

As a key member of our team, you will contribute to the development of cutting-edge products that enhance clinical decision making and positively impact patient outcomes.

Key Responsibilities:
  • Develop efficient manufacturing processes for new medical devices
  • Collaborate with design and engineering teams to streamline product development and manufacturing
  • Work with stakeholders to transfer designs to safe and efficient manufacturing processes
  • Develop and maintain manufacturing documentation, including work instructions, standard operating procedures (SOPs), and assembly guides
  • Prepare document packages for manufacturing, including BOMs, work instructions, and assembly drawings
  • Identify opportunities for process improvements and implement solutions to enhance production efficiency and product quality
  • Support manufacturing by conducting root cause analysis and introducing process improvements
Requirements:
  • Bachelor's degree in an engineering field
  • At least 3 years' experience in a manufacturing environment, preferably in the medical device industry
  • Strong understanding of the medical device industry and/or working under ISO 13485:2016 or similar quality management systems
  • Familiarity with design for manufacturability (DFM) principles and experience applying them in product development
  • Excellent written and verbal communication skills with the ability to collaborate effectively
  • Knowledge of electronic circuits and experience in software scripting is advantageous

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