Principle Engineer
- Round Lake, IL
- Permanent
- Full-time
Bachelor's degree in Engineering (Mechanical, Biomedical, Chemical, Plastics, or a related field).Required Skills:
Technical Expertise: In-depth knowledge of and experience with disposable medical devices (e.g., IV sets, infusion sets).
Manufacturing Knowledge: Strong understanding of various manufacturing processes, including assembly, extrusion, and moulding.
Project Leadership: Proven ability (5-8 years) to lead and/or manage complex technical projects from concept to completion.
Problem-Solving: Demonstrated skill in devising new approaches to complex problems by adapting standard technical principles.
Regulatory Compliance: Experience ensuring product development complies with ISO Standards, FDA, CE Mark, and other country-specific regulations.
Verification & Validation: Proficiency in planning and executing design verification and validation testing.Required Job Description / Responsibilities:
Schedule and lead projects, interfacing with development and technical support groups with minimal guidance.
Supervise and coordinate the work of a Senior Engineer, an Engineer, and/or a coordinator on assigned projects.
Make critical decisions regarding material choice, overall set design, and supplier selection.
Ensure the product meets its intended use for all target countries of sale and is developed per Baxter's Quality and Regulatory standards.
Be responsible for finalizing all project reports, presentations, and documentation.
Assign project tasks within the team to meet committed milestones and project objectives.
Work with the Project Management Office (PMO) to plan project resources, budget, and timelines.
Design products with manufacturability in mind to ensure a smooth design transfer to manufacturing.
Present the work achieved by the team to different stakeholders.Soft Skills:
o Excellent leadership and team coordination abilities.
o Strong prioritization and task management skills.
o Effective communication and presentation skills for interfacing with multiple stakeholders and technical groups.