Process Development Engineer III

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 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 Process Development Engineer III, with some supervision and guidance designs, develops, and optimizes manufacturing processes that ensure medical devices are produced safely, efficiently, cost effectively and in compliance with regulatory standards. The position translates product designs into scalable, robust manufacturing processes that meet quality, cost, and delivery targets.

What You’ll Do

• Support moderately complex cross-functional projects/ initiatives
• Lead design and development of manufacturing processes for novel and existing life sciences products, taking into consideration problems inherent in the transfer of technology from development to production.
• Conducts tests, measurements, process characterizations, process validations, and inspection validations throughout stages of development and production to determine controls over applicable variables and confirm expected process outputs and product requirements are met.
• Prepares product and process reports by collecting, analyzing, and summarizing information results and drawing conclusions and providing recommendations related to processes, equipment, tools and product performance
• Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up.
• Improve existing processes to enhance yield, reduce cost, and increase reliability.
• Apply Lean, Six Sigma, and statistical tools to facilitate decision making and to draw conclusions from available data.
• Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams.
• Evaluate, recommend and or implement new technological equipment, automation and/or materials.
• Identifies, selects, and purchases equipment/fixtures according to development requirements.
• Understands product cost components and its interactions, (direct & indirect material costs, MUV, labor, overhead). Uses product cost knowledge to identify risks and opportunities.
• Performs installation/validation activities for new or existing production lines, meeting regulatory requirements. That includes equipment, process, product and test method validations.
• Leads the creation and implementation of equipment specifications and drawings following company policies.
• Has knowledge of product requirements and specifications, understanding potential risks related to product malfunctions.
• Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions.

Required Qualifications

• Bachelor’s Degree in technical engineering (Mechanical; Electrical; Electronical; Electromechanics; Materials; Chemical).
• 3+ years of working experience on similar roles as manufacturing engineer (sustaining).
• Ability to work independently and collaboratively in cross-functional teams in a fast-paced, changing environment.
• Good communication and presentation skills.
• Good command of the English language, both spoken and written, to effectively communicate in a professional and technical environment.
• Working knowledge of manufacturing systems, automation, and process control.
• Working experience in a manufacturing environment on sustaining engineering activities/process optimization, yield improvement, continuous improvement, non-conformance investigation, and resolution.
• Proficiency in technical writing and documentation.
• Strong analytical and problem-solving skills.
• Experience with continuous improvement methodologies such as lean manufacturing techniques, value stream mapping, or similar.
• Proficient in statistical techniques such as Design of Experiments (DOE), Statistical Process Control (SPC), and data analysis using Minitab or equivalent software.
• Knowledge of FDA, GMP, and ISO guidelines is required.
• Willing to travel
• Advanced Commands of English / Required

SHIFT

• Admin (Monday to Friday 8:00 am to 5:00 pm).
• Works 100% on site

Preferred Qualifications

• 1-3 years of prior experience in medical devices manufacturing.
• Experience as a Manufacturing Engineer within a medical device manufacturing environment, specifically focused on sustaining engineering activities/process optimization, yield improvement, continuous improvement, and non-conformance investigation & resolution.
• Experience with computer-aided design (CAD) software such as SolidWorks or equivalent.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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