Product Development Engineer

Product Development Engineer

Baxter International

Braine-l'Alleud, Belgium

Summary

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.

Qualifications

  • 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,
  • Quality oriented.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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