Senior Manager, Sustaining Engineering
Posted on: November 14, 2022
Job Description: Sr. Manager, Sustaining Engineering or Sr.
Sustaining Engineering Manager Purpose: Provide technical and
professional leadership to the Sustaining Engineering team through
support of activities such as new product introduction, product
sustainment, and cost improvement at AbbVies Dublin California
manufacturing site. Accountable for successful, on-time project
execution, label change management, optimization of manufacturing
processes, engineering change orders, CAPAs, end of life
management, and cost improvement initiatives. Essential Duties and
Responsibilities include the following (other duties may be
- Participate in cross functional communication with Design,
Quality, Document Control, Regulatory Affairs, Supply Chain, and
Manufacturing Operations to support the key initiatives within the
- Manage medical device label change processes to ensure strict
adherence to label requirements as defined by regulatory
- Partner with Process and Software Engineering teams to execute
manufacturing optimization projects.
- Lead the team to implement design and process solutions while
fulfilling the documentation requirements for Class 2 medical
- Work closely with both internal and external stakeholders to
insure conformance to all quality requirements
- Lead CAPA initiatives through all phases, root cause analysis,
identification of corrective actions, change implementation, and
- Identify and prioritize projects such as product/process
continuous improvement, end of life strategies, and cost
- Develop partnerships with internal AbbVie teams for successful
execution of new product introduction initiatives.
- Objectively reviews change orders to ensure adherence to
- Provide training for line personnel, as required.
- Lead and/or participate on project teams to design, develop,
and continuously improve product, equipment, fixtures, and/or
- Capital projects planning and execution. Qualifications:
- Bachelors degree required in mechanical or industrial
engineering, or equivalent technical degree. preferred.
- Minimum o f 8 years of experience including 3 years of
leadership experience with demonstrated success in developing
- Proficiency with CAD tools such as Creo and Solidworks
- Experience with creation and maintenance of medical device
- Experience in an electro-mechanical manufacturing
- Experience using SAP or other enterprise system is
- Experience in change management utilizing PLM tools such as
Arena, Agile, etc.
- Experience in an FDA regulated manufacturing environment and
proficiency with medical device development life cycles is
- Knowledge and understanding of FDA regulations (21CFR 820),
ISO13485, and ISO standards related to medical device manufacturing
- Possesses a strong sense of teamwork.
- Demonstrated written and verbal communication skills. At
AbbVie, we value bringing together individuals from diverse
backgrounds to develop new and innovative solutions for patients.
As an equal opportunity and affirmative action employer, we do not
discriminate on the basis of race, color, religion, national
origin, age, sex (including pregnancy), physical or mental
disability, medical condition, genetic information, gender identity
or expression, sexual orientation, marital status, protected
veteran status, or any other legally protected characteristic. If
you would like to view a copy of the companys affirmative action
plan or policy statement, please email CorpJat_ABV@abbvie.com.
Keywords: AbbVie, Dublin , Senior Manager, Sustaining Engineering, Engineering , Dublin, California
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