Medical Device Manufacturing Specialist

1 week ago

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

This is an exciting opportunity to join a team of experts developing cutting-edge medical devices in a collaborative and innovative environment.

The successful candidate will be responsible for designing and implementing safe and efficient manufacturing processes to transfer new medical devices to the production stage, focusing on DFM principles and quality management systems such as ISO 13485:2016 and ISO9001.

  • Collaborate with cross-functional teams to facilitate the transition from product development to manufacturing, ensuring seamless communication and alignment.
  • Work with stakeholders during product development to transfer designs to safe and efficient manufacturing processes, prioritizing efficiency, quality, and innovation.
  • Develop, review, and maintain manufacturing documentation, including work instructions, standard operating procedures (SOPs), and assembly guides, to ensure compliance and accuracy.
  • Prepare and maintain document packages including BOMs, work instructions, and assembly drawings for manufacturing, to support smooth production and quality control.
  • Identify opportunities for process improvements and implement solutions to enhance production efficiency, product quality, and customer satisfaction.
  • Support manufacturing by conducting root cause analysis, identifying solutions, and introducing process improvements to minimize downtime and optimize performance.
  • Perform verification and validation of manufacturing processes, including equipment qualification and process validation, to ensure regulatory compliance and product safety.
About The Requirements
  • A bachelor's degree in engineering (mechanical, mechatronic, manufacturing, or similar field) with a strong foundation in design, materials science, and mathematics.
  • At least 3 years' experience post-graduation in a manufacturing environment, preferably in the medical device industry, with a proven track record of successfully implementing manufacturing processes and improving productivity.
  • Strong understanding and/or prior experience in the medical device industry and/or working under quality management systems such as ISO 13485:2016 and ISO9001, with knowledge of regulatory requirements and industry standards.
  • Familiarity with design for manufacturability (DFM) principles and experience applying them in product development, to ensure efficient and cost-effective manufacturing processes.
  • Excellent written and verbal communication skills with the ability to collaborate effectively with relevant stakeholders, including design, engineering, and manufacturing teams.
  • Knowledge of electronic circuits and experience in software scripting will be advantageous, but not essential.
About The Company Culture

We are a global leader in microscopic imaging, transforming patient's lives by enabling digital biopsies for cancer screening, diagnosis, and treatment.

Our company culture values collaboration, innovation, and continuous improvement, making it an exciting place to work for those who share these values.

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