Management of project (or part of a project) related to container designquality compliancemedical regulatory regulations change on products on the market
Develop experiments/studies to confirmremediate the functionality of the product:
Evaluate the requirement (if available) otherwise support in the creation of them.
Drafting of technical documents (Protocol, Report, Plan).
Provide technical direction to lab technicians (the only ones performing functional tests).
Analyze and interpret data to guarantee that products meet internal/customer requirements.
Present project updates and study results to internal and external team during recurrent/event based meeting.
Creation of quality documents related to the product in object of the change.
Monitoring of the activities requested by SME.
Cross functional team building and leadership, communication with other functions (materials, toxicology, regulatory, supply chain, manufacturing, quality).
Essential duties and responsibilities
Support in collaboration with related department heads, the plans and strategies pertaining to implementation of projects, in order to meet project timeline,
Provide in depth technical expertise on products design and usage, both in the market and emerging regions,
Effectively support suppliers and team members in the creation and implementation of sustaining and new engineering development,
Provide technical support in the areas of release of new products/line extensions, product improvements, value improvements, changes in regulatory requirements, supplier-initiated changes, and complaint investigations,
Response to enquiries from internal colleagues & from external requests,
Apply state-of-the-art engineering tools/methodologies/principles (sampling plan & study layout definition, data statistical analysis, mechanical design principles...) to design experiments according to applicable Product Development Process and design control procedures,
Provide Container Design support for new and existing Medication Delivery Container Products. Ensuring that products developed meet both internal and external customer requirements,
Based on project needs, the intervention mode of the Engineer will range from punctual on-demand interventions (ex: technical and quality documents edition, test campaign definition & supervision) to longer term integration within a project team,
Lead/be part of cross functional team focused on product support project linked to change of design.
Masters in Engineering and/or Applied Science,
Experience in Pharmaceutical/Medical Device industry,
Fluent in English,
Knowledge of product design, Medical Device Regulation and related therapy requirements,
Ability to organize own work, including support for Change Owners and Study Directors,
High quality protocol & report writing competency,
Ability to make routine decisions independently,
Ability to design experiments and draw meaningful conclusions from lab data,
Self-motivated and take personal accountability for getting the job done,