Manufacturing Engineer

For engineering services in the Manufacturing area.

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: (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 company different 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 industry clients with top-notch quality talent. We're FITS!

Are you the Next Piece?