Senior Electrical Engineer

2 months ago

Saint Paul, Minnesota, United States Abbott Laboratories Full time

About Abbott Laboratories

Abbott Laboratories is a leading global healthcare company that develops and manufactures innovative medical devices, diagnostics, and pharmaceuticals. Our mission is to help people live more fully at all stages of life.

Job Summary

We are seeking a highly skilled Senior Electrical Engineer to join our Electrophysiology (EP) business. As a key member of our development team, you will be responsible for leading the design, development, and testing of complex medical devices.

Key Responsibilities

  • Lead Development Projects
    • Develop and implement complex development projects, including quality improvement initiatives.
    • Set strategies for cross-functional teams and drive towards compliant and efficient solutions to complex problems.
  • Design and Verification
    • Execute on holistic and strategic design verification/validation strategies with emphasis on:
      • Technical analysis of requirements, specifications, and control strategy.
      • Efficient and cost-effective execution of validation and verification.
      • Alignment of design outputs to production and process controls.
      • Proper verification techniques, including inspection, demonstration, test, etc.
  • Design Characterization and Method Development
    • Lead design characterization activities for development projects.
    • Influence design and verification decisions through the use of applied statistics.
    • Support design test and inspection method development, and lead method validation activities.
  • Quality and Compliance
    • Ensure Design History File (DHF) content integrity, completeness, and regulatory/standards compliance.
    • Collaboratively communicate and resolve gaps.
  • Support and Ensure
    • Support and ensure internal and external audit responses and on-time product re-certifications.
    • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Company Initiatives
    • Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Regulatory Compliance
    • Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Education and Experience
    • Bachelor's degree in Engineering or Technical Field; advanced degree/Biomedical Engineering/Electrical Engineering/Computer Science preferred.
    • 5-8+ years of engineering experience with new product development.
    • Working knowledge of design verification and design validation techniques.
    • Working knowledge of applied statistics, sampling strategies, and design of experiments, including statistical software tools such as Minitab.
    • Strong organizational and follow-up skills, as well as attention to detail.
    • Ability to collaborate on-site on a regular basis.
    • Ability to travel approximately 10%, including internationally.
    • Knowledge of FDA, IEC 60601, GMP, ISO 13485, and ISO 14971.
    • Prior medical device experience preferred.

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