JOB DESCRIPTION:
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 Electrophysiology business unit. 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 Engineering Manager, you’ll manage the planning and completion of manufacturing engineering activities in order to meet production goals, while enhancing product quality and productivity.
What You’ll Do
- 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.
- Periodically reviews and analyzes KPI's data and trends.
- Understands financial structure of the organization and its interactions with results.
- Uses product cost structure knowledge to identify risks and opportunities.
- Utilizes KPI's information to provide inputs for the financial cycle (LBE).
- Assures financial results are according to budget.
- Looks for and applies industry best practices related to equipment and process qualification.
- Assures manufacturing lines have equipment requirements fulfilled according to production plan.
- Allocates capital according to company policies.
- Assures maintenance budget is executed and maintained within reasonable variance.
- Uses historical data to drive future equipment selection.
- Has knowledge and expertise on product requirements and specifications.
- Understands potential risks related to product malfunctions.
- Evaluates the financial, process or quality impact, derived from product & process changes.
- Understands potential risks related to product malfunctions.
- Evaluates the financial , process or quality impact, derived from product & process changes.
- Assures validation activities, manufacturing practices and documentation comply with quality & regulatory requirements.
- Interprets data from product and process reports to facilitate decision making.
- Leads or supports local cross functional team activities.
- Participates with external cross functional teams (ie, RA, R&D, QA) representing the ME function.
- Leads the global initiatives with other functions and sites.
- Ensure product conformance to quality standards.
- Leads CAPA investigation processes or provides support allocating resources and implementing corrective/preventive actions
- Has advance knowledge of medical devices regulations: ie FDA’s 21 CFR Part 820 (Quality System Regulation), and 21 CFR Part 11 (Electronic Records; Electronic Signatures) and ISO 13485.
- Leads complex projects as project manager: New product introduction, substantial product changes, line expansions, etc.
- Drives continuous improvement projects according to plan.
- Maintains engineering headcount according to budget.
- Coaches, manages and develops technical staff and functional team members.
- Defines department strategic objectives.
- Develop annual department or projects budget and manage/report variances.
- Function in a controlled environment regulated by FDA GMPs & ISO 13485.
Required Qualifications
- Bachelor’s degree in engineering.
- Experience: 7 years manufacturing/process development experience, with minimum 5 years people management in the following:
- Experience with statistical techniques (e.g., DOE, SPC).
- Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.
- Solid knowledge of GMP, 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.
- Computer software knowledge (Microsoft Word, Excel, Power Point).
- Fully Bilingual (English and Spanish) / Required
SHIFT C (Monday to Friday 10:00 pm to 6:00 am)
Works 100% on site.
Preferred Qualifications & Education
- Willing to travel
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:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Yes
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment
Similar Jobs
.jpg)
What We Do
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
