Manufacturing Engineer: Medical Device Process Validation

Medial Group; Barceloneta (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Medial Group seeks a motivated Manufacturing Engineer to support regulated medical device manufacturing. You will provide technical leadership, drive process improvements, and support validations with minimal supervision in Barceloneta, PR.

Responsibilities include leading project meetings, coordinating internal and external resources, and delivering status reports while ensuring compliance with quality requirements. Fluency in English and Spanish is valued for cross‑functional teamwork.

Qualifications

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

Responsibilities

• Design, develop, communicate, and implement operational plans to complete engineering projects.
• Monitor project progress, timelines, budgets, and deliverables.
• Identify issues, implement corrective actions, and minimize delays.
• Develop engineering designs, work specs, schedules, budgets, and resource plans.
• Coordinate internal resources and external contractors for project execution.
• Collaborate with Engineering, Quality, Validation, Operations, Drafting, and Technical Services teams.
• Lead project meetings with status updates and technical reports.
• Prioritize tasks and coordinate resources to meet milestones.
• Conduct manufacturing studies, process evaluations, and line validations.
• Perform statistical analysis to support projects and improvements.
• Evaluate risks and mitigate to avoid delays.
• Generate, execute, review, and approve qualification and validation protocols/reports.
• Serve as technical liaison between cross-functional teams and Abbott sites.
• Support continuous improvement, cost reduction, and capital initiatives.
• Provide technical leadership for complex assignments requiring independent judgment.

Skills

Manufacturing Engineering

Process Validation

Equipment Qualification

Statistical Analysis

Project Management

Process Improvement

Capital Projects

Cost Reduction Projects

Manufacturing Operations Support

Technical Report Writing

Cross‑Functional Collaboration

Education

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

Job description

Medial Group seeks a motivated Manufacturing Engineer to support regulated medical device manufacturing. You will provide technical leadership, drive process improvements, and support validations with minimal supervision in Barceloneta, PR.

Responsibilities include leading project meetings, coordinating internal and external resources, and delivering status reports while ensuring compliance with quality requirements. Fluency in English and Spanish is valued for cross‑functional teamwork.