Principal Systems Engineer

Our client is a global leader in
diagnostic solutions with a dedication to quality product development to
enhance patient care. In this position, you will play a key role in planning,
conducting and evaluating work to support manufacturing, software, and products
and you will maintain timelines and objectives to procedures and product
development while mentoring junior staff.

 

Responsibilities

 

  • Accountable for documentation of
    design controls, methods while making adjustments to align with the
    corporate mission.
  • Analyzes and interprets data,
    identifying trends and formulating the next steps, while effectively
    performing trade off analysis, if required by the function.
  • Leads, designs and/or develops
    one or more of the following: new test methods, specifications, technical
    apparatus, software and processes for complex components and functions.
  • Recommends design options,
    presents tradeoffs, and helps with risk-based decision making. Evaluates
    complex designs or processes.
  • Identifies issues in product
    development and authors documentation to support continuous improvement.
  • Provides technical support and
    leadership for CAPA and/or complaint investigations.

 

Requirements:

  • BS or MS in relevant discipline
    such as Engineering, Mechanical, or Biomedical
  • 8 + years of related experience
    in product development in the medical device industry
  • Expertise in the application of
    Statistical Analysis, Test Method Development, Design Control, and
    Risk Management
  • Technical Leadership, including
    strong communications, presentations, problem solving, coaching, and
    guiding technical teams

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