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Staff Software Quality Engineer.

Company: Johnson & Johnson
Location: Madison
Posted on: January 16, 2022

Job Description:

NeuWave Medical - Ethicon Endo Surgery Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Software Quality Engineer to be located in Madison, Wisconsin, OR Remote work within the US may be an option.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices (RF & microwave), trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit

NeuWave Medical, Inc. in Madison, Wisconsin, was acquired in 2016 by Johnson & Johnson, primarily due to their innovative devices that have treated thousands of patients with their microwave technology, that continues to lead the industry today.

Our Quality Engineer is responsible for applying the principles of engineering, mathematics, statistics, organizational excellence, and risk management to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Quality Engineer will have orientation to the big picture and attention to detail. Are you interested in joining a team that is developing the next generation of innovative devices that serve our surgeons and patients? Apply today!

Key Responsibilities

  • The Staff Quality Engineer (Software/Systems) will develop, maintain, and continuously improve the software based medical device and digital products quality capability, ensure compliance with procedures and regulatory expectations for existing and new software medical devices and digital products, and develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches
  • Advise and educate key functional partners and management on medical device and digital product requirements, standards and regulations such as IEC 62304, ISO-13485, 21 CFR 820, and EU MDR
  • Ensure product software cybersecurity vulnerabilities are appropriately assessed and documented. Facilitate the implementation of J&J Global Product Security procedures.
  • Plan, lead, and execute continuous improvements to the software quality processes
  • Provide independent design review for other software medical device programs
  • Ensure inspection readiness and maintain CE marks for existing software medical devices
  • Employ key company processes to support projects and quality system processes as required by the position, including following quality procedures and add to the quality system documentation, understanding expected outcomes of key quality processes, and creating or updating risk documents via New Product Development, New Process Introduction, and Lifecycle Engineering.
  • Utilize Risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure modes and effects analysis).
  • Conduct reliability assessments of product design.
  • Perform root cause investigations using various problem-solving techniques and tools and assesses effectiveness of corrective actions.
  • Develop and validate test methods in equipment, process, and product qualifications/validations. Design and execute Measurement Systems Analysis (MSA).
  • Implement and/or maintaining production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics).

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


    • Minimum Bachelor's degree required in Science, Engineering, Technology, or Math or another relevant field.
    • Minimum 5 years of professional work experience in Quality, R&D, New Product Development, Electrical Engineering, Software Engineering, or Computer Science.
    • Experience in Quality Assurance with a focus on software testing, design control of software development, software verification and validation.
    • Knowledge of applied statistics and experience with statistical software applications (e.g., Minitab and/or ReliaSoft)
    • Knowledge of product/process Risk Management (DFMEA/PFMEA Analysis, FDA and/or ISO standards) including cybersecurity assessment.
    • Ability to identify and simplify complex issues, as well as demonstrated ability for proactive, organized, and systemic approach to making decisions and resolving issues
    • Ability to work in a team and demonstrate good interpersonal, organization, and oral/written communication skills

      • A degree in Software Engineering, Electrical Engineering, Computer Electrical Engineering, or Computer Science.
      • Experience in medical device or other highly regulated industry
      • Military veteran leadership experience is an asset
      • Familiarity with medical device regulations (FDA, EU-MDR, etc.)
      • Familiarity with cybersecurity and product security fundamentals
      • Quality Engineering Certification, Software Quality Engineering Certification (e.g., ASQ CQE, ASQ CSQE)
      • Certification (e.g., Black belt) in one or more of the Process Excellence roadmaps (e.g., DMADVV, DMAIC, or Lean)
      • Ability to work independently or autonomously with minimal guidance
      • Application of Design Control fundamentals

        • Requires up to 10% travel, domestic and international

          Primary Location

          United States-Wisconsin-Madison-

          Other Locations

          North America-United States


          NeuWave Medical, Inc. (6229)

          Job Function


          Requisition ID


          by Jobble

Keywords: Johnson & Johnson, Madison , Staff Software Quality Engineer., IT / Software / Systems , Madison, Wisconsin

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