At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

San Jose, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Failure Analysis Engineering Manager, located in San Jose, CA!

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Failure Analysis Engineering Manager oversees day-to-day operations of the failure analysis staff and laboratory facilities within the Post Market Surveillance organization for the Robotics and Digital (RAD) business unit. In addition to management responsibilities, the Failure Analysis Engineering Manager is responsible for performing hands-on technical analysis of sophisticated devices, components, hardware, and software to determine the root cause of failures or device issues, while also mentoring and providing guidance to staff performing similar technical analysis. This manager will become intimately familiar with our medical devices and report out on the root causes identified to assist in the development of countermeasures and product improvements. The Failure Analysis Engineering Manager and the highly technical failure analysis staff play a meaningful role in the development and implementation of continuous improvement efforts within the organization.

Key Responsibilities:

• Collaborate with Engineer, Suppliers, Clinical Specialists, Field Service Engineers, and Manufacturing personnel to facilitate a deep understanding for self and staff of device functionality and failures and to perform in depth root cause analysis.
• Design and execute experiments and test methods to test theories to refine failure modes and determine root cause.
• Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis.
• Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.
• Write formal analysis reports, resulting in clear and accurate messaging about analysis findings to a broad audience.
• Provide frequent verbal and written updates of work-in-progress and data trends for various meetings.
• Enhance investigation methodologies, develop and validate new test fixtures, and mentor the analysis team in the execution of those methods and tools.
• Identifies and coordinates necessary product training for the analysis team.
• Own CAPAs and actions, and drive product and process improvements.
• Oversees delegation of tasks and projects to staff.
• Develops and mentors staff members.

Qualifications

Education:

• Minimum of a Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Computer Science, or related field; an advanced degree in any of these fields is highly desired

Experience and Skills:

Required:

• A minimum of 6 Years of proven experience in a regulated environment (medical device or similarly regulated industry)
• Experience working with ISO 13485 and 14971, GMP Guidelines, FDA regulations
• Sophisticated analytical and problem-solving skills
• Proficiency in root cause analysis tools and techniques (e.g., Hazard Analysis, FMEA, Fault Tree, Pareto diagram, cause-and effect diagrams, 5 whys, etc.)
• Proven understanding and ability in the use of statistical methods including trend analysis, Pareto, and other basic charting techniques
• Confirmed ability to articulate risk and make critical decisions regarding product quality and quality system compliance
• Outstanding communication, presentation, and interpersonal skills working within all levels of the organization
• An approachable individual and dedicated manager who provides a high level of teamwork and multi-functional collaboration

Preferred:

• Six-Sigma, ASQ CQE, or similar certificates are highly desired

Other:

• This position is anticipated to have up to 10% travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

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

The anticipated base pay range for this position is :

$100,000- $173,500

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.