NPI (New Product Introduction) Engineer

Alameda County, CA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

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.

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.

Qualifications:

Bachelors 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.

If you are passionate about launching new medical devices and ensuring compliance in a regulated environment we encourage you to apply.

Ultimate Solutions Corp is an equal opportunity employer.

Required Experience:

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 pro...