Staff Failure Analysis Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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We are searching for the best talent for a Staff Failure Analysis Engineer to be based in Cincinnati OH.

About MedTech

Fueled by innovation at the intersection of biology and technology were 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

You will be responsible for:

• Collaborate with Engineers Clinical Specialists Field Service Engineers and Manufacturing personnel to facilitate a deep understanding 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 part of root cause analysis.
• Write formal analysis reports resulting in clear and accurate messaging about analysis findings for a broad audience.
• Provide frequent verbal and written updates of work-in-progress for various meetings.
• Improve investigation methodologies develop and validate new test fixtures and mentor the analysis team in the execution of those methods.
• Performs other related duties as assigned.

Qualifications/Requirements:

• Bachelor of Science degree in Mechanical Electrical Biomedical Engineering or related field.
• 5 or more years of proven industry experience.
• At least 2 years experience in a regulated environment (medical device aerospace / defense or similarly regulated industry).
• At least 2 or more years of experience conducting Failure Investigation/Analysis in an engineering environment.
• Prior experience in a failure analysis role using data log applications and other test tools in support of failure analysis.
• Solid analytical and problem-solving skills.
• Confirmed ability to articulate risk and make critical decisions regarding product quality and quality system compliance.
• Proficiency in root cause analysis tools and techniques (e.g. Hazard Analysis FMEA Fault Tree Pareto diagrams cause-and-effect diagrams 5 whys etc.).
• Proven understanding and ability in the use of trend analysis Pareto and other basic charting techniques.
• Outstanding communication presentation and interpersonal skills working within all levels of the organization.
• Ability to travel up to 10% international and domestic if required.
• Advanced Degree in Engineering preferred.
• Demonstrated technical knowledge across multiple aspects of mechanical electrical or biomedical engineering preferred.
• Experience working with ISO 13485 and 14971 GMP guidelines FDA regulations preferred.
• Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor preferred.
• Six-Sigma ASQ CQE or similar certifications preferred.

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 & 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 () or contact AskGS to be directed to your accommodation resource.

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Staff IC