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.
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.
#LI-Hybrid
Required Skills:
Preferred Skills:
Corrective and Preventive Action (CAPA), Customer Centricity, Data Savvy, Developing Others, Document Management, Execution Focus, Good Automated Manufacturing Practice (GAMP), Inclusive Leadership, Leadership, Lean Supply Chain Management, Problem Solving, Process Improvements, Quality Control (QC), Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
