Senior Manager, Sustaining Engineering

Company: Disability Solutions
Location: Dublin
Posted on: March 18, 2023

Job Description:

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 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.
• Responsible for 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. Qualifications:
  • Bachelor's degreein mechanical engineering, industrial engineering, electrical engineering or closely related discipline is required, or equivalent technical experience plus demonstrated competency with desired 10+ years of significant engineering and/or operations experience. A post-graduate education/degree is desired and may contribute towards the desired years of experience.
  • Minimum 3 years of people leadership experience/leading team(s) with demonstrated success in developing talent.
  • Minimum 5 years experience in an electro-mechanical, assembly and test manufacturing environment.
  • Has demonstrated excellence across multiple engineering disciplines.
  • Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
  • Proficiency with CAD tools such as Creo and Solidworks preferred.
  • Experience with creation and maintenance of medical device labels.
  • 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.Applicable to California Applicants Only
    • The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California. This range may be modified in the future.
    • The salary range for this role is posted below
      • This job is eligible to participate in our short-term incentive program
      • This job is eligible to participate in our long-term incentive programs
      • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
      • Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.Significant Work Activities: N/ATravel: NoJob Type: ExperiencedSchedule: Full-timeCompensationMinimum Salary $110,500 Maximum Salary $216,000

Keywords: Disability Solutions, Dublin , Senior Manager, Sustaining Engineering, Engineering , Dublin, California