Summary:

We are seeking a motivated and experienced Manufacturing Engineer to support manufacturing operations within a regulated Medical Device or Pharmaceutical environment. The selected candidate will provide technical leadership, execute engineering projects, drive process improvements, and support manufacturing validations while working with minimal supervision.

This role requires strong analytical and problem-solving skills, the ability to manage multiple engineering projects, and collaboration with cross-functional teams to ensure manufacturing excellence and compliance with quality and regulatory requirements.

Responsibilities:

Design, develop, communicate, and implement operational plans to successfully complete engineering projects.
Monitor project progress, performance, timelines, budgets, and deliverables.
Identify operational issues, implement corrective actions, and minimize project delays.
Develop engineering designs, work specifications, project schedules, budgets, and resource plans.
Coordinate internal resources and external contractors to support project execution.
Collaborate with Engineering, Quality, Validation, Operations, Drafting, and Technical Services teams.
Lead and coordinate project meetings while providing regular project status updates and technical reports.
Prioritize tasks and coordinate project resources to meet established milestones.
Conduct manufacturing studies, process evaluations, and line validations as required.
Perform statistical analysis to support engineering projects and process improvements.
Evaluate project risks, implement mitigation strategies, and proactively resolve issues before impacting project timelines.
Generate, execute, review, and approve qualification and validation protocols and reports with minimal supervision.
Serve as the technical liaison between cross-functional teams and other Abbott manufacturing sites.
Support continuous improvement, cost reduction, and capital improvement initiatives.
Provide technical leadership for complex manufacturing engineering assignments requiring independent judgment and creative problem-solving.
Recommend innovative technical solutions when established procedures or precedents do not exist.

Requirements

Education

Bachelor's Degree in Mechanical Engineering, Electrical Engineering, Manufacturing Engineering, Industrial Engineering, Software Engineering, or related Engineering discipline.

Experience

Minimum of 2 years of engineering experience in the Medical Device or Pharmaceutical industry.
Experience supporting manufacturing engineering projects in regulated environments.
Ability to work independently with minimal supervision.

Preferred Qualifications

Experience with Equipment and Process Validations (IQ/OQ/PQ).
Experience supporting Product Transfers.
Experience managing Capital Projects.
Experience leading Continuous Improvement initiatives.
Experience with Cost Improvement Projects.
Knowledge of statistical analysis and process optimization.
Experience authoring and approving validation protocols and reports.

Technical Skills

Manufacturing Engineering
Process Validation (IQ/OQ/PQ)
Equipment Qualification
Statistical Analysis
Risk Assessment & Risk Mitigation
Project Management
Process Improvement
Capital Projects
Continuous Improvement
Cost Reduction Projects
Manufacturing Operations Support
Engineering Documentation
Technical Report Writing
Cross-Functional Collaboration

Soft Skills

Excellent analytical and problem-solving skills.
Strong project planning and organizational abilities.
Ability to anticipate issues and develop proactive solutions.
Excellent verbal and written communication skills.
Ability to lead technical discussions across multidisciplinary teams.
Self-driven with the ability to work independently with minimal guidance.

Languages

Fluent in English and Spanish (written and verbal).

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