Sr Principal Engineer

Baxter International

Braine l'Alleud, Belgium

Summary:

Professional with experience in the following areas i.e. Polymer, Material Sciences, Medical Devices, Product Requirements management, Traceability, DHF structure & maintenance, Product Risk management, Container System verification & Validation is required. This position will take the PDO and PRMO responsibilities & perform relevant sustaining and product development activities for a family of medical devices as they are used in Advanced Surgery portfolio.

Essential Duties and Responsibilities:

Will take the PDO and PRMO responsibilities for selected medical devices as part of the Advanced Surgery portfolio;
Should have expertise in the study of polymer and polymeric composites, evaluation of material properties and an ability to carry out root cause analyses in case of product failures, material change impact assessments;
Will provide project management with an ability to drive materials and V&V tests in a timely manner across several global, cross-functional projects;
Will be responsible for the development and delivery of materials and mechanical testing, verification test protocols, test cases and reports;
The role would involve organization and presentation of technical work and deliverables to the global project team(s) in a well-planned manner with a clear logical flow;
Will be responsible for project management which includes managing change controls –using Baxter’s in-house quality systems like TW8, TcU;
Should have a deep knowledge of polymer science with an ability to study and understand chemical analysis data along with an understanding of mechanical testing and property of materials;
Will be able to leverage own expertise as well as inputs from others to identify and resolve critical issues;
Will perform troubleshooting and problem-solving efforts related to material aspects of the products associated with field performance and manufacturing;
Mentor or may manage juniors in the area of his/her expertise;
Responsible for development of state-of-the-art industry expertise and driving continuous improvements by staying on top of the latest relevant technologies in the industry;
Will have ownership of the elements of Design History File and Risk Management File;
Works independently with the team(s) and/or leads the project team on the deliverables. Responsible for defining scope of work for project-based team and managing resources effectively.

Qualifications:

PhD/Master’s degree in Polymer Science/Engineering and Mechanical Engineering or related field;
Demonstrated ability to work in a matrix environment with multiple stakeholders;
A proven track record of effectiveness in a fast-paced environment working in global teams;
Proven ability to deliver results by owning & being accountable for budget, timeline, and product/project deliverables;
Knowledge & experience of medical devices, product development stages and life cycle management: development, stability, clinical, registration, process/technology transfer, production, suppliers;
Working knowledge/familiarity of international/regional/national regulations and standards;
Solid computer skills: email, documentation and collaboration tools: e.g. WebEx, Teams, Microsoft Office products, etc. Skills of engineering tools is a plus: i.e CAD, etc.;
Demonstrates flexibility and the ability to shift gears between projects comfortably;
Able to manage junior engineers and interact with global counterparts. Identify opportunities to collaborate with other teams;
A proven track record of leading complex size projects – especially Product Design Change Controls, Material Change Controls in Medical/Healthcare industry;
Identify and report any quality or compliance concerns and take immediate corrective/Preventive action as needed;
Project management experience highly desired. Excellent stakeholder management (local and global);
Knowledge and experience in six sigma methodologies for leading investigations, identifying root cause investigations and driving solutions.