Key Responsibilities:
* Lead the design, development and performance evaluation of drug-device combination products to ensure compliance with regulatory and quality standards.
* Provide subject matter expertise for the development of Combination Products.
* Plan and execute design verification and reliability strategies to guarantee product quality.
* Serve as a technical interface between drug product and device teams during combination product development, ensuring formulation and manufacturing activities are compatible and aligned.
* Develop test methods and specifications to assess device functionality and product performance including procurement and implementation of new lab testing equipment.
* Responsible for material assessment of device components including biological evaluation, extractables profiling and material certification.
* Support manufacturing sites during filling and assembly process development by providing device controls and sampling plans.
* Utilize statistical techniques or data analysis such as hypothesis testing, confidence and tolerance intervals, regression, capability analysis, DOEs, etc., to inform design decision making and conclusions for deliverables like test method validations, design characterizations and verification, and reliability.
* Ensure all team activities are conducted and executed according to quality standards within the Quality Management system.
* Lead support activities for external and internal audits and inspections as required.
Requirements:
* Bachelor's degree in Science/Engineering; Master's preferred.
* 7+ years' experience in pharmaceutical and/or medical device development.
* Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 is an advantage.
* Experience in the development and validation of analytical methods.
* Skilled in the application of statistical techniques for data analysis.
* Experience of writing and supporting regulatory submissions.
* A highly motivated individual who can work effectively in a dynamic team environment while taking responsibility for individual tasks in a Subject Matter Expert role.
* Excellent communication skills to lead or facilitate effective discussions. Ability to communicate technical and project information to key stakeholders.
* Some travel may be required for this role.
This permanent position is based in our Dublin office, where you will join a dynamic team working on innovative projects.