Principal Engineer, Medical Devices — R&D & Design Leader

Baxter International Inc.; Deerfield (IL); On-site; USD 112,000 - 154,000; Full time

Job summary

Baxter International Inc. in Deerfield, IL, is seeking an experienced engineer to lead design control, CAPA, and development activities for our Advanced Surgery portfolio.

You will collaborate with R&D, Operations, Quality, and Regulatory teams to deliver robust designs on schedule and within budget. The ideal candidate has a biomedical/mechanical engineering background, 5+ years in product development, strong CAD and prototyping skills, and proven ability to document work, present results, and

Qualifications

• B.S. in engineering discipline (preferably Biomedical/Mechanical), MS or PhD preferred, with 5+ years in product development.
• Experience in creating/managing design documentation and transfer of products into manufacturing.
• Proficient in 3D CAD Software.
• Experience in prototyping, testing, and evaluating mechanical designs.
• Skilled at written and verbal presentations within the business/technical community.
• Demonstrated ability to contribute to technical projects through successful outcomes.
• Must be self-motivated, resourceful, flexible; a self-starter is imperative.
• Preferred experience with TQM, statistical methods, problem analysis and resolution, materials science, and DOE.

Responsibilities

• Achieves technical outcomes through Design Control, CAPA, CC deliverables within time and budget.
• Technical oversight of a changing portfolio impacting R&D, Operations, QS, Process, Customer or Supply Chain.
• Lead and collaborate with cross-functional teams to meet schedule and project demands.
• Review and approve design changes and provide technical product direction for the project team.
• Foster rigor, completeness and compliance in CAPA/CC/FCA investigations.
• Be accountable as a technical SME to drive product development deliverables such as formulation or process development.
• Demonstrate adherence to FDA, ISO, IEC design control procedures and standards.
• Create design concepts and research methodologies meeting current/future customer and business needs.
• Use critical thinking and teamwork to resolve competing constraints.
• Create and maintain DHF documents: verification/validation reports, drawings, specifications.
• Develop and execute study plans and reports.

Skills

3D CAD

Prototyping

Technical presentations

Cross-functional collaboration

Design control

Self-motivated

Education

B.S. in engineering

MS or Ph.D. preferred

Job description

Baxter International Inc. in Deerfield, IL, is seeking an experienced engineer to lead design control, CAPA, and development activities for our Advanced Surgery portfolio.

You will collaborate with R&D, Operations, Quality, and Regulatory teams to deliver robust designs on schedule and within budget. The ideal candidate has a biomedical/mechanical engineering background, 5+ years in product development, strong CAD and prototyping skills, and proven ability to document work, present results, and