Principal Engineer — Medical Devices & Design Controls

Baxter Healthcare

Deerfield (IL)

On-site

USD 112,000 - 154,000

Full time

14 days+

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Job summary

Baxter Healthcare in Deerfield, IL is seeking an experienced Design Engineer for the Advanced Surgery division. You will develop and sustain engineering solutions, lead cross-functional teams, and ensure design controls and documentation meet regulatory standards.

Ideal candidates hold a 5+ year track record, strong CAD and prototyping skills, and are self-starting with excellent communication. The role offers a competitive base salary and potential discretionary bonuses.

Qualifications

B.S. in engineering (Biomedical/Mechanical) with 5+ years in product development.
Experience creating/managing design documentation and transfer of products into manufacturing.
Proficient in 3D CAD software.
Experience prototyping, testing, and evaluating mechanical designs.
Strong written and verbal presentation skills.
Self-motivated, resourceful, flexible; a self-starter.
Preferred: TQM, statistical methods, problem analysis and resolution, materials science, and DOE.

Responsibilities

Achieve technical outcomes through Design Control, CAPA, CC project deliverables within timing and budget.
Provide 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 & project demands.
Based on technical expertise, review and approve design changes and provide technical product direction for the project team.
Foster rigor, completeness and compliance in CAPA, CC, or FCA investigations/assessments.
Drive product development deliverables such as formulation development, process development, or tech transfers.
Ensure adherence to FDA, ISO, and IEC design control procedures and standards.
Create and maintain DHF documents (verification/validation reports, drawings, specifications).
Develop and execute study plans and reports.