Manufacturing Process Engineer
hace 1 mes
Abbott Laboratories is a global healthcare leader, renowned for creating innovative solutions to improve people's lives. We're committed to anticipating changes in medical science and technology.
Our Company Culture
We value work that matters, growth, learning, self-care, and being true to oneself. At Abbott, you'll have access to:
- Career development with an international company where you can grow your career.
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies globally by Fortune.
- A company that prioritizes diversity, working mothers, female executives, and scientists.
The Opportunity
This role works out of our Alajuela location. As the Manufacturing Process Engineer, you'll develop and implement optimal manufacturing processes and methods in line with product specifications and quality standards; recommend and implement improvements to production processes, methods, and controls; and be responsible for activities related to installation and validation of production lines, as well as lifecycle management of equipment.
Your Responsibilities
- Daily support to manufacturing activities to meet established goals for safety, quality, cost, and production.
- Based on key performance indicators data such as yield, nonconforming material or leadtime, take action to maintain indicators under control and promote continuous improvement.
- Use statistical techniques to facilitate decision-making and draw conclusions from available data.
- Understand product cost components and its interactions (direct & indirect material costs, MUV, labor, overhead).
- Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
- Perform installation/validation activities for new or existent production lines, meeting regulatory requirements (equipment, process, product, and test method validations).
- Estimate validation activities cost and ensure it's budgeted within the financial cycle.
- Identify, select, and purchase equipment/fixtures according to production requirements, due to obsolescence, redundancy, or line capacity expansion. Have direct relation with vendors to define equipment suitability.
- Keep equipment operational by coordinating calibration, maintenance, and repair services; follow manufacturer's instructions and established procedures; request special service when needed.
- Analyze equipment data, trends, and performance to assure correct lifecycle management and identify and mitigate risks associated with equipment technical knowledge, spares availability, and external technical service.
- Evaluate the financial, process, or quality impact derived from product & process changes.
- Have clear criteria of conforming/non-conforming product and the test methods used for verifying conformance.
- Able to navigate and execute activities on manufacturing systems (e.g., update routers, BOMs, or generate new part numbers and ZFINs).
- Maintain MP's current and compliant to regulations ensuring practices at the manufacturing floor adhere to them.
- Lead or support local cross-functional team activities. Support/Lead global initiatives with other functions and sites (e.g., RA, R&D, QA).
- Lead or support CAPA investigation processes, or exception documents such as complaints investigations.
- Identify and implement continuous improvement projects for any of the main key areas: safety, quality, production, and cost, using the appropriate project management tools.
- May supervise and provide technical assistance to exempt and non-exempt personnel, being accountable for their correct training and performance management.
- Provide inputs for the departmental budget preparation.
Salary Information
$120,000 - $180,000 per annum, depending on experience.
Required Qualifications
- Bachelor's degree in STEM careers.
- 6+ years of manufacturing/process development experience.
- Statistical techniques knowledge (DOE, SPC) required.
- Computer software knowledge (Microsoft Word, Excel, PowerPoint).
- Willing to travel.
- Experience with continuous improvement methodologies (lean manufacturing techniques, value stream mapping, or similar).
- Knowledge of FDA, GMP, and ISO guidelines required.
- Experience leading validation plans for medical industry products and processes and leading root cause problem-solving methodologies.
- Experience in project management.
- Advanced command of English required.
- Available to work 100% on-site (Coyol, Alajuela).
- Shift Administrative (Monday to Friday, 8:00 am - 5:00 pm).
Preferred Qualifications
- (3-5) + years prior experience in medical devices manufacturing.
- Performance management.
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