NPI (New Product Introduction) Engineer

Ultimate Solutions • San Lorenzo, PR

11h • Onsite

About The Position

NPI Engineer – Medical Device (Validation & Equipment Qualification) Ultimate Solutions Corp. is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in Puerto Rico, United States and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices, and logistics markets. Location: San Lorenzo, Puerto Rico Industry: Medical Device We are seeking an experienced NPI Engineer to support New Product Introduction (NPI) initiatives within a regulated medical device manufacturing environment. This role will focus on validation execution and equipment qualification to ensure successful product launches in compliance with FDA and ISO requirements.

Requirements

• Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
• 3+ years of experience in Medical Device manufacturing.
• Strong experience in Equipment Qualification (IQ/OQ/PQ) and process validation.
• Experience with change control and documentation management systems.
• Strong technical writing and communication skills.
• Bilingual (English/Spanish) is a Must.

Responsibilities

• Support New Product Introduction (NPI) projects from development transfer through commercial launch.
• Execute and document Equipment Qualification protocols (IQ, OQ, PQ).
• Develop and review validation documentation
• Support process validation activities and manufacturing readiness.
• Collaborate with cross-functional teams including Quality, Manufacturing, R&D, and Regulatory Affairs.
• Provide technical support during equipment startup and validation phases.
• Ensure compliance with cGMP, GDP, and internal quality systems.

What This Job Offers

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