Process Development Engineer

2 days ago

Auckland City, New Zealand Aroa Biosurgery Full time

At AROA, our people come to work every day with passion and ideas that fuel our business and go home knowing they have made a real difference in the lives of others.

AROA, which is Maori for ‘understanding’, is proudly New Zealand born and based. We develop, manufacture, and export innovative wound care products, improving the lives of millions around the world by unlocking extraordinary outcomes for our patients. Our mission is to be the global leader in regenerative healing, making our products and services accessible to everybody.

**About the role**:
We are seeking a Process Development Engineer to ensure the quality and reliability of our medical device products from pilot processes to commercial scale-up and transfer. This position will focus on the development and validation of sterilization and cleaning processes in compliance with relevant regulatory standards and guidelines. You must have the ability to collaborate effectively with internal stakeholders including engineering, manufacturing, quality and regulatory teams. Other key responsibilities include:

- Plan and execute process development studies
- Perform validation activities such as, but not limited to, IQ/OQ/PQ
- Collaborate with internal stakeholders, Engineering, and Quality teams to ensure smooth transfer of new processes into manufacturing
- Support Design Controls in process risk assessment activities (e.g. pFMEA) where technical input is required
- Identify opportunities for process optimisation and efficiency improvementsPerform root cause analysis to support manufacturing activities

**What you’ll bring**:

- Bachelor’s degree in science or engineering
- 3+ years’ experience in a similar role and experience in medical, pharmaceutical, or other highly regulated sectors is welcome
- Hands-on experience with terminal sterilization of medical devices and the development and validation of cleaning processes
- Experience in process development and validation
- Comfortable using statistical analysis tools (e.g., Minitab)Project management skills and experience working in both laboratory and workshop environments are desirable but not essential
- **What we offer**:

- Birthday leave (your special day off)
- Health & wellbeing benefits, including free on-site gym and fitness classes.
- Free on-site parking and easy motorway access.
- A diverse, supportive, and inclusive culture where achievements are celebrated.The chance to be part of a mission-led company doing work that’s never been done before.

At AROA, you’ll join a team that works hard, values collaboration, and celebrates success—while contributing to life-changing innovations in regenerative healing.

To be considered for this opportunity you must have existing NZ working rights.

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