Staff Software Quality Engineer.
Company: Johnson & Johnson
Posted on: January 16, 2022
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 www.ethicon.com.
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!
- 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
- 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
- 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
- Provide independent design review for other software medical
- 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
- 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
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
- 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
- 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
- Military veteran leadership experience is an asset
- Familiarity with medical device regulations (FDA, EU-MDR,
- Familiarity with cybersecurity and product security
- 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
- Application of Design Control fundamentals
- Requires up to 10% travel, domestic and international
North America-United States
NeuWave Medical, Inc. (6229)
Keywords: Johnson & Johnson, Madison , Staff Software Quality Engineer., IT / Software / Systems , Madison, Wisconsin
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