Sr. Engineer, Process & Product

Baxter International Inc. • Aibonito, PR

8d • Onsite

About The Position

As a Senior Engineer, Process & Product, you will play a critical role in supporting manufacturing operations and driving process excellence within our Medical Devices & Solutions manufacturing site in Aibonito. You will partner with cross-functional teams locally and globally to introduce new products, implement process improvements, execute validation activities, and ensure compliance with corporate quality standards and regulatory requirements. This position provides the opportunity to lead projects, influence manufacturing strategy, and contribute to a culture of continuous improvement.

Requirements

• Bachelor's degree in Mechanical, Industrial, Electrical, Chemical Engineering, or a related engineering discipline.
• 3–5 years of engineering experience in manufacturing, product engineering, project engineering, or a closely related industry.
• Strong project management, organizational, and communication skills.
• Experience applying engineering problem-solving methodologies and statistical analysis techniques.
• Knowledge of validation processes, process improvement methods, and manufacturing change management practices.
• Understanding of Design Control requirements and regulated manufacturing environments.
• Strong interpersonal and collaboration skills with the ability to work effectively across functions and global teams.
• Ability to manage multiple priorities and projects with minimal supervision.
• Bilingual proficiency in Spanish and English, both written and verbal.

Nice To Haves

• Familiarity with Six Sigma, Lean Manufacturing, or Total Quality Management (TQM) methodologies preferred.

Responsibilities

• Support manufacturing operations by providing technical leadership and engineering expertise for process and product-related activities.
• Participate in and contribute to cross-functional projects that support plant manufacturing strategies and business objectives.
• Analyze and resolve manufacturing and process-related issues using standard and advanced engineering principles and problem-solving methodologies.
• Independently identify manufacturing challenges and provide timely support to production and operations teams.
• Lead and support new product introductions, product design modifications, and manufacturing improvement initiatives.
• Serve as a Change Control Owner and/or Action Owner for local and divisional projects, ensuring successful implementation of process and product changes.
• Develop, execute, and maintain process and product validation and revalidation programs in collaboration with local and divisional engineering resources.
• Manage technical resources and prioritize workloads to effectively support validation and manufacturing activities.
• Coordinate and execute product and process transfer activities from divisional and international manufacturing sites to the Aibonito facility.
• Lead small project teams and provide technical guidance to achieve project goals and timelines.
• Independently manage multiple engineering and product development activities in accordance with Product Development Process requirements.
• Support internal and external audits, including MDSAP, Corporate, FDA, and other regulatory inspections.
• Serve as a Technical Approver within assigned areas of responsibility.
• Apply engineering and statistical tools such as PFMEA, 5 Whys, Design of Experiments (DOE), Process Modeling, Mold Flow Analysis, SPC, and Six Sigma methodologies to support investigations and process improvements.
• Drive Value Improvement Projects (VIP) through process analysis and continuous improvement initiatives.
• Perform statistical and analytical evaluations of process and product performance to identify opportunities for improvement.
• Collaborate effectively with divisional teams and international manufacturing facilities while working with minimal supervision.
• Promote a zero-harm workplace by supporting Environmental Health & Safety (EHS) initiatives and ensuring compliance with all applicable safety requirements.
• Maintain confidentiality and adhere to data privacy standards and company policies.

Benefits

• Medical, Dental, Disability and Life Insurance coverage
• Vision Plan
• Paid Vacation Days and Paid Holidays
• Paid Parental Leave
• Retirement Plan
• Employee Stock Purchase Program
• Educational Assistance Plan
• health and well-being benefits include medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior