- 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.
- Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
- Understands financial structure of the organization and its interactions with results.
- Uses product cost knowledge to identify risks and opportunities.
- Performs installation/validation activities for new or existent production lines, meeting regulatory requirements. That includes equipment's, process, product and test method validations.
- Leads or supports CAPA investigation processes, or exception documents such as complaints investigations, NCMR's.
- Bachelor's degree in engineering preferable in technical 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).
- 5 years prior experience in medical device manufacturing preferred.
- Performance management.
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Manufacturing Engineering Section Leader - Alajuela, Costa Rica - Abbott
Descripción
The Opportunity
This position works out of our Costa Rica, Zona Franca Coyol – 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'll have the chance to 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 installation and validation of production lines as well as the lifecycle management of equipment.
What You'll Do
Shift B: Monday – Friday: 3:30 pm to 10:00 pm and Saturdays: 8:00am - 3:30 pm
Required Qualifications
Preferred Qualifications