Process Development Engineer

For Process Development services in the Process Engineering area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor Degree in Engineering ( Mechanical or Electrical ) and at least five (5) years of experience within the medical devices or pharmaceutical industry.
• Bilingual: English and Spanish
• Soft Skills: Great attitude and strong desire to learn new skills. 
• Shift: Administrative, and according to business needs. 
• Experience in:
  • 21 CFR Part 820, GMP, and ISO 13485 regulations. 
  • Electrical and mechanical engineering applied to automated manufacturing systems.
  • Automation/controls, tooling, fixtures, test method development, and equipment qualification.
  • DOE, FMEA, CAPA, and root‑cause investigation.
  • Supporting new product introductions and process scale‑up.

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of  your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Support IQ/OQ/PQ and process performance qualification activities; develop validation protocols, reports, and master validation plans.
• Design and develop in‑process and receiving inspection systems for new components and processes.
• Generate equipment documentation (evaluations, PM/calibration procedures) and manufacturing instructions.
• Manage process development projects from concept through implementation; collaborate with cross-functional teams.
• Apply DOE, PFMEA, and risk analysis to characterize, optimize, and improve manufacturing processes.
• Work with technologies such as laser welding, heat bonding, injection molding, vision systems, and automation (PLC/servo/pneumatics/sensors).

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in 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?