Principal Scientist/Engineer Medical Device DevelopmentOur Dublin based client are currently recruiting for a highly skilled Principal Scientist/Engineer to join their Device and Product Performance team on a permanent basis.
In this role, you will lead the design, development, and performance evaluation of drug-device combination products, ensuring they meet regulatory and quality standards.
Your expertise will drive technical excellence, innovation, and patient-centric solutions.
Responsibilities
Provide subject matter expertise to support the development of Combination ProductsPlan and execute design verification and reliability strategiesBe the technical interface between drug product and device teams during combination product development ensuring formulation and manufacturing development activities are compatible and align with device developmentResponsible for the development of design requirements and specifications based on characterization of comparator products, regulatory requirements, design intent and user requirementsDevelop test methods and specifications to assess device functionality and product performance including evaluation, procurement & implement new, state-of-the-art lab testing equipment as applicableResponsible for material assessment of device components including biological evaluation, extractables profiling and material certificationProvide technical support to manufacturing sites during filling and assembly process development by providing device controls and sampling plansUse of 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 reliabilityEnsures all activities within team are conducted and executed to the appropriate quality standards within the Quality Management systemLead support activities for external and internal audits and inspections as applicable
Requirements
Degree in Science/Engineering (Master's preferred)7+ years' experience in pharmaceutical and/or medical device developmentWorking knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantageExperience in the development and validation of analytical methodsExperienced in application of statistical techniques for data analysisExperience of writing and supporting regulatory submissionsHighly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks in a Subject Matter Expert roleWell-developed communication skills to lead or facilitate effective discussions.
Able to communicate technical and/or project information to key stakeholdersSome travel will be required as part of this role
For more information, please contact Sinéad Cullen on +353879500821 or ******