Project Engineer

Abbott•Arecibo, PR

4d•$54,300 - $109,000•Onsite

About The Position

This position will provide support to Abbott Cardiac Rhythm Management, located in Arecibo, PR. This is an onsite position. 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. Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries. This position works out of our Arecibo location in the Cardiac Rhythm Management 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 a Project Engineer, 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

Minimum 3 years exposure in Process Validation and Development within the Medical Device Industry or pharmaceutical industries. Engineering role.
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.