Project Engineer, this position will provide support to Abbott Cardiac Rhythm Management, located in Arecibo, PR.
This is onsite position.
The Opportunity
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.
What You’ll Do
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.
Required Qualifications
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.
Apply now
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
The base pay for this position is
$54,300.00 – $109,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Engineering
DIVISION:CRM Cardiac Rhythm Management
LOCATION:Puerto Rico > Arecibo : Santana Industrial Park Interior Lot A, Road #2, Km 67.5
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Keyboard use (greater or equal to 50% of the workday)
