Senior Engineer

1 week 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. 

MÄÂÂÂori for ‘understanding’, AROA 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 every body.

We are seeking a **Senior Engineer - Process Validation**to ensure the quality and reliability of our medical device products from pilot processes to commercial scale-up and transfer. This position demands expertise in validation, strong project management skills, and the ability to collaborate effectively with internal stakeholders including engineering, manufacturing, quality and regulatory teams.

**Your key responsibilities**:

- Plan, execute, and manage process development and validation studies
- Collaborate with internal stakeholders, Engineering, and Quality teams to ensure smooth design transfer of new products into manufacturing
- Generate technical protocols and reports
- Support Design Controls in process risk assessment activities (e.g. pFMEA) where technical input is required
- Identify opportunities for process optimisation and efficiency improvements
- Perform root cause analysis to support manufacturing activities

** What you’ll bring**:

- Bachelor’s degree in biomedical or chemical engineering
- Minimum of 5 years’ experience working in the medical device industry, (pharmaceutical or highly regulated field will be also considered)
- Experience with process validation and sterilization processes
- Familiarity with statistical analysis software and tools (Minitab)
- Strong project management skills and a collaborative mindset

Experience working in laboratory and workshop

Based in Airport Oaks with easy access to the motorway, there is plenty of free parking available around our offices. We also have an onsite gym, exercise classes and celebrations (including taking your birthday off).

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

Applications for this role will close **14 March 2025.



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