Manufacturing Engineer

FITS LLC; Ponce (PR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

FITS LLC in Puerto Rico is seeking a seasoned engineering professional to lead manufacturing transfers and process implementations for medical devices. The role requires a Bachelor’s degree in an engineering discipline and 5+ years of relevant experience, with strong IQ/OQ/PQ execution and regulatory familiarity.

Ideal candidates are bilingual (Spanish and English) and capable of working with cross-functional teams to ensure launch readiness, risk mitigation, and compliant manufacturing

Formación

• 5+ years in medical device manufacturing, product transfers, or NPI.
• Bilingual in Spanish and English.
• Experience with FDA, ISO 13485, and GMP requirements.
• Experience on cross-functional project teams and manufacturing transfers.

Responsabilidades

• Lead manufacturing transfer and process implementation activities.
• Develop manufacturing documentation including BOMs, routers, work instructions, and specifications.
• Execute equipment qualifications and process validations.
• Support engineering builds, pilot runs, and production readiness assessments.
• Participate in PFMEA and manufacturing risk mitigation activities.
• Ensure manufacturing readiness for successful product launch.

Conocimientos

Bilingual Spanish & English

Educación

Bachelor's degree in Mechanical/ Industrial/ Manufacturing/ Biomedical Engineering

Herramientas

IQ/OQ/PQ

FDA ISO 13485 GMP

Descripción del empleo

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Mechanical, Industrial, Manufacturing, Biomedical, or related Engineering discipline.
• 5+ years of experience in medical device manufacturing, product transfers, or new product introductions (NPI).
• Bilingual: Spanish and English
• Shift: Administrative,and according to business needs.
• Experience in:
  • Process Validation (IQ/OQ/PQ), equipment qualification, manufacturing process development, and continuous improvement initiatives.
  • Familiarity with FDA, ISO 13485, and GMP requirements.
  • Participating in cross-functional project teams and manufacturing transfers is highly preferred.

AS A PIECE OF FITS, YOU WILL:

• Lead manufacturing transfer and process implementation activities.
• Develop manufacturing documentation including BOMs, routers, work instructions, and specifications.
• Execute equipment qualifications and process validations.
• Support engineering builds, pilot runs, and production readiness assessments.
• Participate in PFMEA and manufacturing risk mitigation activities.
• Ensure manufacturing readiness for successful product launch.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent. We're FITS!

Are you the Next Piece?