Staff Failure Analysis Engineer

Johnson & Johnson Innovative Medicine • Cincinnati, OH

20h • Hybrid

About The Position

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, 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.

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.

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior