Job Description: Sr. Manager, Sustaining Engineering or Sr. Sustaining Engineering Manager
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 AbbVie’s 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 assigned):
- Participate in cross functional communication with Design, Quality, Document Control, Regulatory Affairs, Supply Chain, and Manufacturing Operations to support the key initiatives within the CoolSculpting business.
- Manage medical device label change processes to ensure strict adherence to label requirements as defined by regulatory affairs.
- 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 devices.
- 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 effectiveness check.
- Identify and prioritize projects such as product/process continuous improvement, end of life strategies, and cost improvement initiatives.
- Develop partnerships with internal AbbVie teams for successful execution of new product introduction initiatives.
- Objectively reviews change orders to ensure adherence to standards.
- 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 processes.
- Capital projects planning and execution.
- Bachelor’s degree required in mechanical or industrial engineering, or equivalent technical degree.
- Minimum of 8 years of experience including 3 years of leadership experience with demonstrated success in developing talent.
- Proficiency with CAD tools such as Creo and Solidworks preferred.
- Experience with creation and maintenance of medical device labels.
- Experience in an electro-mechanical manufacturing environment.
- Experience using SAP or other enterprise system is preferred.
- 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 preferred.
- Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing is preferred.
- Possesses a strong sense of teamwork.
- Demonstrated written and verbal communication skills.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced