Failure Investigation Team Lead

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 jnj.com

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.

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

People Leader

All Job Posting Locations:

Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for Failure Investigation Team Lead to join our Abiomed Quality organization located in Danvers, MA.

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

The Team Lead, PME in the Post Market Engineering group plays an integral role in Abiomed’s Quality Department as a people leadership role supporting a team conducting post market investigations of FDA approved medical devices. In this position you will lead people and processes to conduct complaint failure investigations and support CAPAs and engineering products. 

Key Responsibilities

• Responsible for identifying and researching failures to improve product quality and reliability.
• Lead projects by developing a project plan and schedule and by adhering to design controls
• Lead Technical Discussions with team.
• Responsible for timely complaint closure across the team.
• Responsible for leading training and onboarding of new team members
• Supports development of team members
• Manages deliverables from key stakeholders across the organization
• Fosters an environment that encourages thinking outside of the box and inventive approaches to problem solving & performing investigations more effectively.
• Maintains extensive knowledge of all Abiomed products
• Establish root cause failure analysis techniques, processes and test methods to improve efficiency and effectiveness
• Drive completion of all corrective and preventive actions in a timely manner 
   

Qualifications

• A minimum of a Bachelor’s degree is required. Degrees in Mechanical Engineering or directly related scientific discipline, or MS preferred.
• 3+ years of related experience in mechanical engineering
• Must have knowledge of statistical tools and analytical software such as, MiniTab & Matlab
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives
• Must have a working knowledge of applicable manufacturing processes such as injection molding, extrusion and fabrication.
• Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written)
• Ability to exercise judgment methods, techniques and evaluation criteria for obtaining results. 
• Execute tasks in a timely manner without direct supervision
• Ability to prioritize tasks and effectively manage time
• Must be proficient Microsoft Office Suite
• Medical Device experience preferred. 
• Green Belt 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.  

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