Let’s talk about the team
As a Reprocessing Engineer II within the Resmed Reprocessing Team, you will be part of a team of subject matter experts responsible for the development and execution of verification and validation of the cleaning, disinfection and labelling of ResMed medical devices.
The reprocessing team owns, develops and maintains the reprocessing strategy in compliance with relevant regulations; ISO17664-1 and -2, ISO15883, ISO10993, ST98, TIR12, and TIR55. The team’s reach extends across various product development groups globally, ensuring that Resmed's products meet healthcare customer expectations through safe and compliant business activities. We pride ourselves on constantly adapting and relentlessly improving to maximize the value that we add to the broader organization.
This is a role for someone who demonstrates solid technical capability and can independently deliver high-quality outcomes while collaborating effectively across teams. You will apply sound engineering judgement to solve real-time problems and consistently deliver robust, compliant reprocessing solutions. You will create and validate cleaning and disinfection instructions for a wide range of Resmed medical devices, working collaboratively with teams across marketing, medical affairs, product development, and systems engineering. You will bring a methodical and detail-oriented approach to ensure scientific rigour is maintained across a variety of complex medical products.
Let’s talk about the role
- Develop and optimize reprocessing methods and instructions for the cleaning and disinfection of respiratory medical devices, ensuring solutions are robust and compliant
- Work collaboratively with cross-functional product development teams including marketing, product development, regulatory, clinical, labelling and quality representatives, proactively identifying risks, trade-offs, and dependencies to influence effective outcomes
- Manage stakeholder expectations and proactively communicate progress, risks, and trade-offs to enable informed decision-making
- Independently author and review cleaning and disinfection test protocols, laboratory studies, and reports for ResMed medical devices with a high level of scientific rigour
- Coordinate and guide external laboratory activities to ensure testing is executed efficiently and meets required quality standards
- Contribute to regulatory submissions by providing clear, accurate, and defensible technical documentation
- Provide guidance and share reprocessing best practices with cross-functional teams to improve overall capability
- Stay informed on relevant standards and regulations and contribute insights within the team
- Independently conduct and interpret microbiological risk assessments pertaining to the risk of infection, applying sound judgement to recommend appropriate controls
- Support regulatory audits and confidently present technical work when required
- Consistently solve complex and ambiguous problems, balancing technical, regulatory, and business considerations
- Actively contribute to maintaining and improving corporate knowledge regarding:
- Hygiene for respiratory devices
- Infection control standards and regulations
- Worldwide cleaning, disinfection best practices and trends
- Clinical studies on cross-infection risks and the effectiveness of controls
- Preferred practices for infection control in healthcare
Let’s talk about you
Required:
- Relevant bachelor’s degree in engineering or science field
- Solid understanding of relevant standards and regulations
- Demonstrated ability to independently execute technical work with limited guidance
- Excellent written and verbal communication skills, with the ability to clearly convey technical concepts to both technical and non-technical stakeholders
- Ability to work independently as well as part of a collaborative team
- Proactive approach to identifying efficiencies and improvement opportunities
- Strong attention to detail and commitment to scientific rigour
Preferred:
- Experience validating cleaning, disinfection or sterilization methods (e.g. bioburden, bacterial reduction determination)
- Knowledge of communicable pathogens and precautions
- Working knowledge of global reprocessing standards, process validation methodology and practice
- Experience contributing to technical reports, regulatory documentation, or similar deliverables
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Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.
