AbbVie

Senior Process Engineering Manager

Employer
AbbVie
Location
Dublin, CA, United States
Posted
Feb 20, 2021
Ref
2102275
Required Education
Bachelors Degree
Position Type
Full time
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Summary:

Responsible for development and optimizing manufacturing processes, from engineering change control through the production and shipment of product. This includes review of BOM's and accurate translation into SAP. Also responsible for mentoring other technical staff members and training them to perform SAP entry and line support functions.

Essential Duties and Responsibilities include the following (other duties may be assigned.):

• Manage a group of process engineers supporting Coolsculpting, Envy and TrueTear product lines.

• Serve as the primary line support engineer and lead other technical staff members in the support and improvement of production line processes and procedures.

• Review ECO's to ensure correctness of the BOM's and transfer the information from Arena (our document control system) into SAP.

• Check, validate, and enter the Item Master to ensure correctness.

• Work with Production and Materials groups to address BOM issues, in order to facilitate accurate and efficient back-flushing and inventory management.

• Manage ECO implementations into the production environment.

• Set up necessary carts and bins to facilitate proper materials management on the production floor.

• Perform time studies, when needed, to assess line capacity and to identify areas to improve.

• Create and maintain a model of the production line to determine capacity and proactively initiate purchase requests for additional equipment, furniture, tooling, and fixtures that will be needed for volume increases.

• Create layouts and execute plans to expand the production line, and to add new products in a manner that optimizes floor space.

• Improve production line efficiency, flexibility, and work environment to improve yield, capacity, and product quality.

• Lead complex projects to introduce new products to the production line and to improve existing tooling, fixtures, and procedures.

• Document and update work instructions, as needed to maintain and improve the production line.

• Lead efforts to track, report, and improve production yields to meet or exceed target goals.

• Perform investigations into line failures, NCMRs, and line issues, and document findings accordingly.

• Assist in the processing of NCMRs, when needed.

• Perform engineering work typically including one or more of the following:

o Process/product improvements

o Process development including IQ/OQ/PQ

o Process improvements including Validation & Verification

o Product design for manufacturability, testability and serviceability

o Production line layout & facility requirements

o Report preparation

• Provide training for line personnel, particularly on new processes and process improvements.

• Lead and/or participate on project teams to design, develop, and continuously improve product, equipment, fixtures, and/or processes.

• Perform failure analysis on failed units from field returns.

• Work with Quality to resolve part quality issues from supplier/vendors.

• Reduce costs through manufacturing process improvement or component costs.

Qualifications

Qualifications:
  • Bachelors degree in mechanical or industrial engineering, or equivalent technical degree or experience, plus at least 8 years of relevant experience in a manufacturing environment is required.
  • Experience using SAP or other enterprise system to set up BOM's and parts management in support of a manufacturing line is required.


  • Strong understanding of BOM structures and use of Phantom BOM's for proper material consumption.
  • Arena (or equivalent change management system) experience is required.
  • Experience in an FDA regulated manufacturing environment and proficiency with medical device development life cycles is required.
  • Ability to focus on and achieve scheduled milestones, including contingency planning is required.
  • Knowledge and understanding of FDA regulations (21CFR 820), ISO13485, and ISO standards related to medical device manufacturing is preferred.
  • Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.
  • Ability to use MS Excel to perform calculations, charting, and interpret results/data.
  • Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.
  • Pro-E competency is desirable.


Additional Requirements:

Responsible for performing all duties in compliance with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ZELTIQ complies.

Language and Verbal Skills:

Individual must have excellent verbal and written communication skills and a demonstrated ability to communicate clearly and professionally.

Math Skills:

Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Analytical and Reading Skills:

Ability to read, understand and abide by company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.

Physical Requirements:

The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; up to 8 hours per day. The employee is regularly required to lift and carry up to 10 pounds and occasionally lift and carry up to 25 pounds. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision.

Work Environment:

Most work is performed in an office-like setting. The noise level in the environment is usually low to moderate.

Safety:

Zeltiq is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity 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.