Senior Manufacturing Engineer – Shift Admin
Abbott · Alajuela
Description du poste
About the role
Abbott is seeking a Senior Manufacturing Engineer to lead cost‑effective manufacturing processes for its Electrophysiology division in Alajuela, Costa Rica. The role focuses on installation, validation, and lifecycle management of production equipment while ensuring compliance with FDA, GMP, and ISO standards.
Key responsibilities
- Develop and implement optimal manufacturing methods aligned with product specifications and quality standards.
- Perform installation and validation activities for new or existing production lines, including equipment, process, product, and test method validations.
- Estimate validation costs, manage budgets, and ensure financial compliance.
- Select and purchase equipment/fixtures to meet production needs, address obsolescence, and expand line capacity.
- Update manufacturing systems such as routers, BOMs, part numbers, and ZFINs.
- Lead or support cross‑functional teams and global initiatives with R&D, QA, and regulatory affairs.
Required profile
- Bachelor’s degree in a STEM field with 7+ years of manufacturing/process experience.
- Strong knowledge of statistical techniques (DOE, SPC) and continuous‑improvement methodologies (lean, value‑stream mapping).
- Experience leading validation plans and root‑cause problem‑solving in the medical‑device industry.
- Project‑management experience coordinating cross‑functional teams.
- Fully bilingual in English and Spanish.
- Willingness to travel and work on‑site (8 am‑5 pm shift).
Required skills
- Design of Experiments (DOE)
- Statistical Process Control (SPC)
- Microsoft Word, Excel, PowerPoint
- Lean manufacturing techniques
- Value‑stream mapping
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Abbott
Alajuela