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NPI (New Product Introduction) Engineer
San Lorenzo, Puerto RicoNPI 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.
Key Responsibilities:
Ultimate Solutions Corp is an equal opportunity employer.
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.
Key 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.
- 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.
Ultimate Solutions Corp is an equal opportunity employer.