Manufacturing Engineering Section Leader

hace 3 semanas

Alajuela, Costa Rica Abbott Laboratories A tiempo completo

**Position for Shift B**

MAIN RESPONSABILITIES
- 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
- Understand 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, process, product and test method validations.
- Estimates validation activities cost and assures it is budgeted within the financial cycle.
- Looks for and applies industry best practices related to equipment and process qualification.
- Assures manufacturing lines have equipment requirements fulfilled according to the 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.
- Understands potential risks related to product malfunctions.
- 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.
- 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/non-conforming product and the test methods used for verifying conformance.
- Able to navigate and excecute 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.
- Maintains MP's current and compliant to regulations. Ensures practices at the manufacturing floor adhere to them.
- Supports DL's & IDL's training process.
- 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.
- Suppors the team to meet quality indicators.
- Leads or supports CAPA investigation processes, or exception documents such as complaints investigations, NCMR's.
- Leads complex projects as project manager: New product introduction, substantial product changes, line expansions, etc.
- Identifies and implements continuous improvement projects for any of the main key areas: safety, quality, production and cost.
- May supervise and provide technical assistance to exempt and non-exempt personnel, being accountable for their correct training and performance management.
- Provides inputs for the departmental budget preparation.

**_
QUALIFICATIONS_**
- Bachelor’s degree in Engineering
- 7+ years of manufacturing/process development experience
- Experience with statistical techniques (e.g., DOE, SPC). Is required.
- RCPS Subject Matter Expert
- Experience with continuous improvement methodologies. Such as lean manufacturing techniques, value stream mapping, or similar.
- Solid knowledge of FDA, GMPs, and ISO regulations. Is required
- At least 2+ years of experience managing exempt technical personnel (Engineers)
- Experience leading teams and 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 experience
- Experience working on product ramp-ups under a pressure environment in order to meet goals and KPIs.

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