Manufacturing Engineer

FITS, LLC; Ponce (PR); Presencial; USD 80.000 - 120.000; Jornada completa

Descripción de la vacante

FITS, LLC in Puerto Rico provides engineering services for the Manufacturing area. The role focuses on leading manufacturing transfer, process implementation, and readiness for new product introductions in the medical device sector.

You will develop documentation (BOMs, routers, work instructions), perform equipment qualifications and process validations, support pilot runs and production readiness, participate in PFMEA and risk mitigation, and ensure readiness for product launches while

Formación

• 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.

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

Process validation

Equipment qualification

Manufacturing process development

Continuous improvement

Cross-functional teamwork

Bilingual (Spanish-English)

Educación

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

Herramientas

FDA compliance awareness

ISO 13485

GMP knowledge

Descripción del empleo

WHAT MAKES YOU A FIT:

For engineering services in the Manufacturing area.

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: (The day-to-day on the job)

• 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!