Failure Investigation Team Lead

Johnson & Johnson•Cherry Hill, NJ

19h•Hybrid

About The Position

The Team Lead, PME in the Post Market Engineering group at Abiomed's Quality Department is a people leadership role. This position involves leading a team that conducts post-market investigations of FDA-approved medical devices. The role focuses on leading people and processes to perform complaint failure investigations and support Corrective and Preventive Actions (CAPAs) and engineering products.

Requirements

A minimum of a Bachelor’s degree is required.
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.

Nice To Haves

MS preferred (in Mechanical Engineering or directly related scientific discipline).
Medical Device experience preferred.
Green Belt preferred.

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.

Benefits

Consolidated retirement plan (pension)
Savings plan (401(k))
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