Process Development Engineer

Flexible & Integrated Technical Services, LLC • Dorado, PR

22h

About The Position

For Process Development services in the Process Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor Degree in Engineering 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?

Requirements

• Bachelor Degree in Engineering and at least five (5) years of experience within the medical devices or pharmaceutical industry.
• Bilingual: English and Spanish
• Great attitude and strong desire to learn new skills.
• 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.

Responsibilities

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level