Principal Engineer

3 weeks ago

Minneapolis, Minnesota, United States Baxter Healthcare Corporation Full time
About the Role

Baxter is seeking a highly skilled Principal Engineer to join our Peritoneal Dialysis Product Quality Engineering Team. As a key member of our team, you will be responsible for providing quality oversight and mentorship to project teams, ensuring that Quality Engineering principles are applied to develop and improve products that are robust, safe, and effective.

Key Responsibilities
  • Develop, review, and approve Design History File (DHF), Design Master Record (DMR), risk management, verification, validation, and other product development documents.
  • Ensure compliance to applicable Baxter policy, procedures, and regulations.
  • Provide direction and critical reviews for Development Planning, Design Inputs, Design verification and Validation, Peer Technical and Design Reviews, Risk Management, and Labeling review.
  • Collaborate with Baxter plant, external partners, and corporate groups to transfer new and improved products.
  • Analyze manufacturing data, reports, statistics, and documentation to identify and address quality issues and process improvements.
  • Offer mentorship to project personnel regarding the appropriate application of design, statistical, and analytical tools.
  • Lead CAPA related activities as appropriate.
  • Monitor and report on critical metrics for CAPA during monthly governance meetings.
  • Identify areas for improving regulatory compliance and continuous improvement opportunities for products and processes.
  • Compile trending information from quality inputs (nonconformance, FCA, complaints, MDR, etc.) using Microsoft Excel for sustaining products organization.
  • Prepare and issue monthly PQDR (product quality data reports) based on information analysis.
  • Support both internal and external audits.
Requirements
  • Bachelor's degree in Engineering (Biomedical, Mechanical, or Electrical preferred).
  • At least 8 years of experience in Quality, Engineering, or Manufacturing or related field.
  • Relevant experience supporting products in a regulated environment is required.
  • At least 4 years of Quality Engineering experience is preferred.
  • Understanding of global Regulatory and Quality requirements for medical devices, including ISO 13485, FDA Quality Systems Regulation, ISO 14971, MDD 93/42/EEC, EU MDR, and other relevant international laws.
  • Outstanding problem-solving and analytical skills.
  • Excellent communication and interpersonal abilities.
  • Ability to perform multiple tasks simultaneously with compliance to Standard Operation Procedures and Regulatory requirements.
  • Ability to work collaboratively in a global and team-oriented environment.
  • Balance multiple activities, priorities, and deadlines.
  • Good technical skills (e.g., spreadsheet, databases, and online research).

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