Project Engineer

Abbott; Arecibo (PR); On-site; USD 54,000 - 109,000; Full time

Benefits offered by this job

Health insurance (Day 1)

401K with company match

Life insurance

Short/Long Term Disability

Education assistance

Vacation

Sick days

Personal days

Job summary

Abbott is seeking a Project Engineer to support the Cardiac Rhythm Management group in Arecibo, PR. This onsite role focuses on developing and executing cost-improvement and technology-transfer projects in a regulated manufacturing setting.

The candidate will generate validation protocols, coordinate with cross-functional teams, and support NPI and process transfers. A minimum of 3 years in process validation within medical devices or pharma is expected, with FDA/GMP/ISO knowledge preferred and

Qualifications

• Minimum 3 years of experience in Process Validation and Development within the medical device or pharmaceutical industries.
• Knowledge of FDA, GMP, and ISO guidelines is preferred.
• Fully bilingual in English and Spanish.
• Strong computer software knowledge: Word, Excel and PowerPoint.

Responsibilities

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

Skills

Process Validation

DOE

SPC

Communication skills

Bilingual (English/Spanish)

Education

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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.

Project Engineer, this position will provide support to Abbott Cardiac Rhythm Management, located in Arecibo, PR.

This is onsite position.

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 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, managers, 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.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.