This position is within the Drug Delivery Systems & Packaging (DDSP) department of CSL Technical Operations. The role focuses on the development of drug delivery devices from concept through commercialization and product maintenance, with an emphasis on leading user interface development and ensuring products meet patient needs. The team is transitioning from primarily executing formative and summative studies to more front-end development work, including evaluation and selection of device and packaging components and user interface development.
Tasks
- Act as Lead Human Factors Engineer.
- Plan and execute Human Factors Engineering activities in drug delivery device projects, including development of secondary packaging and Instructions for Use.
- Set and drive best practices within DDS&P for Human Factors Engineering.
- Support standardization of approaches for Task Analysis, Use Risk Assessment, and other key deliverables.
- Lead Human Factors oversight of secondary packaging development.
- Partner with project leads and the cross-functional development team on planning and execution of projects.
- Lead development of selection criteria and evaluation of the user interface for new products.
- Collect, maintain, and utilize data on user capabilities and known use problems with combination products.
- Contribute to the development of Company Core Data Sheets (CCDS).
- Plan and execute Formative and Summative evaluations, including selection and oversight of CROs.
- Leverage existing data to support regulatory submissions, such as comparative analysis.
- Develop dossier submissions for Human Factors content, including HFE/UE Report, and responses to regulatory agency questions.
- Monitor industry trends, standards, and regulatory guidance.
Requirements
- Excellent communication skills and a track record working in a matrix environment.
- Ability to influence and promote a culture of continuous improvement.
- Subject Matter Expertise on IEC 62366 family of standards and related regulatory guidance.
- Expertise in user capabilities, including anthropometric basis.
- Experience with Use Risk Assessments.
- Proven track record of evaluation of user interfaces for drug delivery devices.
- Experience in development of instructional materials for product labelling and artwork.
- Relevant academic qualification in an appropriate field, such as Ergonomics, Psychology, or a suitable Science or Engineering degree.
- At least 8 years of related experience in the pharmaceutical or medical device industry.
- Ability to travel internationally up to 20%.
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