Engineer II, Reprocessing Engineering (Medical Devices)

TL;DR

Engineer II, Reprocessing Engineering (Medical Devices): Developing and executing verification and validation of cleaning, disinfection, and labelling for respiratory medical devices with an accent on regulatory compliance and scientific rigour. Focus on creating compliant reprocessing instructions, conducting microbiological risk assessments, and managing technical documentation for regulatory submissions.

Location: Sydney, NSW, Australia

Company

hirify.global is a global leader in medical technology specializing in respiratory devices to improve patient health.

What you will do

• Develop and optimize reprocessing methods and instructions for the cleaning and disinfection of respiratory medical devices.
• Collaborate with cross-functional teams (marketing, regulatory, quality) to identify risks and dependencies.
• Author and review cleaning and disinfection test protocols, laboratory studies, and reports with high scientific rigour.
• Coordinate and guide external laboratory activities to ensure testing meets quality standards.
• Conduct and interpret microbiological risk assessments to recommend appropriate infection controls.
• Contribute to regulatory submissions by providing accurate and defensible technical documentation.

Requirements

• Bachelor’s degree in engineering or a science field.
• Solid understanding of relevant standards and regulations (e.g., ISO17664, ISO15883, ISO10993).
• Demonstrated ability to execute technical work independently with limited guidance.
• Excellent written and verbal communication skills for both technical and non-technical stakeholders.
• Strong attention to detail and commitment to scientific rigour.

Nice to have

• Experience validating cleaning, disinfection, or sterilization methods (e.g., bioburden, bacterial reduction).
• Knowledge of communicable pathogens and precautions.
• Working knowledge of global reprocessing standards and process validation methodology.
• Experience contributing to technical reports or regulatory documentation.

Culture & Benefits

• Culture driven by excellence, innovation, and a commitment to making the world a healthier place.
• Diverse and inclusive work environment that encourages individual expression.
• Supportive and inspiring career paths with a focus on meeting and creating new goals.
• Guaranteed response to every applicant.