Abbott

Manufacturing Engineering Section Leader

Costa Rica - Alajuela Full time

JOB DESCRIPTION:

Manufacturing Engineering Section Leader

SHIFT B: Monday to Friday 3:30 pm to 10:00 pm and Saturday 8:00 am to 3:30 pm. 

Works 100% on site 

 

About Abbott 

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.  

 

Working at Abbott  

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:  

  • Career development with an international company where you can grow the career you dream of. 

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.  

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.  

 

The Opportunity  

This position works out of our Costa Rica – Alajuela location in the EP Division In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives. 

As the Manufacturing Engineering Section Leader, you will provide leadership to engineering or cross functional teams to  meet the business results.  The manufacturing engineer position develops and implements optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards; recommends and implements improvements to production processes, methods and controls; is also responsible for the activities related to instalation and validation of production lines as well as the lifecycle management of equipment.    

 

What You’ll Do  

1. Leadership and Team Management

  • Provides leadership to engineering staff regarding project prioritization, process validations, and continuous improvement activities.
  • Leads the team to maintain Key performance indicators under control. Provides prioritization & allocates engineering resources, according to business needs.
  • May supervise and provide technical assistance to exempt and non-exempt personnel, being accountable for their correct training and performance management.

2. Process and Validation Management

  • Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipments, process, product and test method validations.
  • Estimates validation activities cost and assures it is budgeted within financial cycle.
  • Looks for and applies industry best practices related to equipment and process qualification.

3. Equipment and Maintenance Management

  • Assures manufacturing lines have equipment requirements fulfilled according to production plan.
  • Keeps equipment operational by coordinating calibration, maintenance and repair services.
  • Analyzes equipment data, trends, and performance to assure correct lifecycle management. Uses historical data to drive future equipment selection.

4. Financial Analysis and Continuous Improvement

  • Understands financial structure of the organization and its interactions with results. Uses product cost knowledge to identify risks and opportunities.
  • Evaluates the financial, process or quality impact derived from product & process changes. Uses statistical techniques to facilitate decision making and to draw conclusions from available data.
  • Identifies and implements continuous improvement projects for any of the main key areas: safety, quality, production and cost.
  • Provides inputs for the departmental budget preparation.

5.Compliance and Quality

  • Has knowledge and expertise on product requirements and specifications.
  • Assures that production lines output meet the specifications of the product. Has clear criteria of conforming/nonconforming product and the test methods used for verifying conformance.
  • Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.
  • Supports DL's & IDL's training process.
  • Supports the team to meet quality indicators.
  • Leads or supports CAPA investigation processes, or exception documents such as complaints investigations, NCMR's.

6. Information and Systems Management

  • Able to navigate and execute activities on manufacturing systems for example: update routers, BOM's or to generate new part numbers and ZFINs.
  • Coordinates the activities related to new ZFIN's implementation.
  • Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

7. Project and Cross-Functional Team Participation

  • Leads or supports local cross functional team activities.
  • Participates with external cross functional teams (ie, RA, R&D, QA) representing the ME function. Leads global initiatives with other functions and sites.
  • Leads complex projects as project manager: New product introduction, substantial product changes, line expansions, etc.

 

Required Qualifications 

  • Bachelor’s Degree in STEM careers 

  • 7+ years of manufacturing/process development experience or demonstrated combination of experience / skills in equivalent or similar positions

    ·       Experience with statistical techniques (e.g., DOE, SPC). Is required.

    ·       Computer software knowledge (Microsoft Word, Excel, Power Point). 

    ·       Willing to travel

    ·       Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.

    ·       Solid knowledge of FDA, GMPs and ISO regulations.         

    ·       Experience leading validation plans for medical industry products and processes and leading root cause problem solving methodologies.

  • Experience in project management involving coordination of cross-functional teams.

  • Fully Bilingual (English and Spanish) /  Required

 

Preferred Qualifications 

  • 5 years prior experience in medical device manufacturing preferred.            
  • Performance management

  

**This position works for new technology VOLT:

PFA Ablation Device
Cutting-edge technology for cardiac ablation procedures, utilizing Pulsed Field Ablation (PFA) to deliver precise, efficient, and tissue-selective treatment for arrhythmias. Designed to minimize collateral damage and enhance patient safety while improving procedural outcomes.

 

 

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. 

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Manufacturing

DIVISION:

EP Electrophysiology

LOCATION:

Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2

ADDITIONAL LOCATIONS:

WORK SHIFT:

Crcww2Nt (Costa Rica)

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Work in a clean room environment