Staff Design Quality Engineer

n Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit https://www.depuysynthes.com.

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention and general surgery. This includes the Power Tools and VELYS platform, where we are building connected technologies powered by data insights before, during, and after surgery and designed to elevate the orthopedic experience for patients, surgeons, and care teams.

Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.

Our work schedule is hybrid, with three days in the office and two remote.

Key Responsibilities:

• Product development team member passionate about product development and lifecycle management activities associated with Power Tools.

• Participate in all aspects of the creation and execution of functional/design requirements for new and sustaining projects.

• Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.

• Apply basic and sophisticated statistical methods to design verification and validation activities (e.g., hypothesis testing, DOE, ANOVA, R&R studies, capability, tolerance interval analysis, power and sample size determinations, etc.).

• Support risk management activities including planning, design & clinical risk management and overall risk summary reporting.

• Lead the cascade of critical to quality design features to product quality requirements and downstream manufacturing & quality processes.

• Provide leadership in the Quality System Areas, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

• Work closely with suppliers on the qualification of new/changed parts and processes supporting product development.

• Support internal audits and external audits by regulatory agencies, as required.

Qualifications

Education:

• Bachelor of Science degree in Engineering, Electrical Engineering, or Biomedical Engineering, or relevant degree; Advanced Degree is preferred.

Experience

Required:

• Four to six (4-6) years of related experience with a focus on design control, risk management, and verification & validation

• At least five (5) years of Quality experience within the medical device, aerospace, defense or similarly regulated industry

• Experience with the application of Data Science and Advanced Statistical Techniques

• Strong verbal and written communication skills; ability to present issues, plans and objectives.

• Excellent interpersonal, problem solving, and analytical skills

• Ability to lead priorities and workflow versatility, flexibility, and a willingness to work within constantly evolving priorities

Preferred :

• Solid understanding of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA's General Principles of Software validation.

• Passion for development of new technologies, including the ability to apply design controls to new technologies.

Other:

• This position may require up to 10% domestic and international travel.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit https://www.careers.jnj.com.