Senior Principal Engineer, Human Factors

This role is a position in the Drug Delivery Systems & Packaging (DDSP) department within CSL Technical Operations. The ideal candidate has a solid track record in the development of drug delivery devices, from concept development through commercialization and product maintenance. This role requires experience in leading user interface development and a passion for making the right product that meets the needs of the patients. The ideal candidate will understand how CSL drug delivery devices operate and the interface to users and will translate this into design of the user interface and instructional materials. CSL is looking to transform our Human Factors Engineering team from mainly executing formative and summative studies to more front-end development work. This includes evaluation and selection of commercially available device and primary packaging components, as well as user interface development to meet user needs.

Responsibilities • 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 HF 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, e.g., comparative analysis

• Develop dossier submissions for HF content, including HFE/UE Report, and responses to regulatory agency questions

• Monitor industry trends, standards, and regulatory guidance

Qualifications • 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

• User Capabilities – anthropometric basis

• Use Risk Assessments

• Proven track record of: • Evaluation of user interfaces for drug delivery devices

• Development of instructional materials for product labelling and artwork

• Relevant academic qualification in an appropriate field, e.g., 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%