Project Engineer

Abbott•Arecibo, PR

1d•Onsite

About The Position

Project Engineer, this position provide support to Cardiac Rhythm Management site, located in Arecibo, Puerto Rico. 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. Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days. 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 Arecibo location in the CRM division. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats. As the Project Engineer you will be under direct supervision from Senior Project Engineering or Project Manager, this position has the responsibilities to develops, manages, and executes cost improvement, product/process, and technology transfer projects. Works with the optimization of process specifications and procedures for proper design, manufacturing, and inspection parameters. Will support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment. Will be responsible to generate and execute validation protocols, feasibility studies, coordinate work with corresponding functional areas for new or replaced equipment, or process changes.

Requirements

Bachelor's Degree Engineering, Industrial, Chemical, Mechanical, Electrical.
Minimum 3 years exposure in Process Validation and Development within the Medical Device Industry or pharmaceutical industries.
Experience in a related engineering role preferably in the medical device industry.
Knowledge of FDA, GMP, and ISO guidelines is preferred.
Experience with statistical techniques (DOE, SPC) is preferred.
Strong computer software knowledge (Microsoft Word, Excel, Power Point).
Knows fundamental concepts, practices, and procedures of a particular field of specialization.
Effective communication and presentation skills.
Fully Bilingual (English and Spanish).
Computer literacy in programs as; Excel, Word & Power Point.

Responsibilities

Develops, manages, and executes cost improvement, product/process, and technology transfer projects
Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
Generate and execute validation protocols (IQ, OQ, PQ, TMV, TQF, Process Characterization and Process Validation based on equipment capabilities.
Conduct process equipment installation/operational/performance qualification studies to test their functionality.
Support New Products Introduction (NPI) and Process transfer activities in a regulated manufacturing environment.
Other duties as assigned.

Benefits

Career development with an international company where you can grow the career you dream of.
Health Insurance (starting on Day 1 of employment)
Savings Plan (401K) with company match
Life insurance for you and your spouse/children
Short Term Disability
Long Term Disability
Education Assistance
Employee Assistance Program
Vacation
Sick
Personal Days