Sr. Manufacturing Engineer

Medial Group; Barceloneta (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Medial Group is seeking a Senior Manufacturing Engineer to support a product transfer project within a regulated medical device manufacturing environment. The candidate will lead manufacturing engineering activities, validation efforts, and cross-functional collaboration to ensure successful transfers and compliant documentation.

The role requires independence, strong English communication, and proven problem-solving skills to optimize quality, efficiency, and reliability across processes and

Qualifications

• Bachelor's Degree in Mechanical, Electrical, Software, Manufacturing, or related Engineering.
• Minimum 5 years of Manufacturing Engineering experience.
• Hands-on IQ, OQ, and PQ validations.
• Ability to work independently with minimal supervision.
• Strong written and conversational English communication skills.
• Excellent analytical, troubleshooting, and problem-solving skills.
• Strong organizational and project management abilities.

Responsibilities

• Lead manufacturing engineering activities supporting product transfer projects.
• Plan, execute, and support equipment and process validation activities, including OQ/PQ.
• Generate technical reports, validation protocols, and engineering documentation.
• Analyze manufacturing processes and recommend improvements to optimize quality, efficiency, and reliability.
• Lead complex engineering assignments involving cross-functional teams.
• Identify technical issues proactively and develop practical solutions with minimal supervision.
• Collaborate with Quality, Operations, Validation, and other engineering disciplines to ensure project success.

Skills

IQ/OQ/PQ validations

Manufacturing engineering

Analytical skills

Project management

Education

Bachelor's degree in Engineering

Job description

Barceloneta, Puerto Rico | Posted on 07/10/2026

We are seeking an experienced Senior Manufacturing Engineer to support a product transfer project within a regulated medical device manufacturing environment. The ideal candidate will have strong experience in manufacturing engineering, process validation, technical documentation, and engineering support while working independently with minimal supervision.

This role requires a proactive engineering professional capable of leading complex technical activities, identifying manufacturing challenges, recommending effective solutions, and supporting successful product transfer initiatives.

Responsibilities

• Lead manufacturing engineering activities supporting product transfer projects.
• Plan, execute, and support equipment and process validation activities, including:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Generate technical reports, validation protocols, and engineering documentation.
• Analyze manufacturing processes and recommend improvements to optimize quality, efficiency, and reliability.
• Lead complex engineering assignments involving multiple cross-functional teams.
• Identify technical issues proactively and develop practical solutions with minimal supervision.
• Evaluate manufacturing processes and implement improvements where required.
  • Collaborate with Quality, Operations, Validation, and other engineering disciplines to ensure project success.
  • Participate in peer reviews of engineering work, validation activities, and technical documentation.
  • Ensure compliance with applicable quality systems and engineering standards.

Requirements

• Bachelor's Degree in Mechanical, Electrical, Software, Manufacturing, or related Engineering discipline.
• Minimum 5 years of Manufacturing Engineering experience.
• Hands-on experience executing IQ, OQ, and PQ validations.
• Experience supporting product transfer projects (preferred).
• Experience generating technical reports and engineering documentation.
• Ability to work independently with minimal supervision.
• Strong written and conversational English communication skills.
• Excellent analytical, troubleshooting, and problem-solving skills.
• Strong organizational and project management abilities.

Preferred Experience

• Medical device or other regulated manufacturing industry.
• Product transfer or new product introduction (NPI).
• Manufacturing process optimization.
• Cross-functional project leadership.
• Technical documentation and validation lifecycle support.