Process Engineer
Añasco, PR, Puerto Rico
Contracted
Medical Devices
Mid Level
For Engineering services in the Injection Molding area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s degree in Engineering and at least five (5) years of previous experience in Process Engineering activities within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent communication skills and a positive attitude.
- Shift: Administrative shift (M-F 8:00AM to 5:00PM)
- Experience in:
- Scientific molding (RJG, DOE, Decoupled Molding).
- Strong troubleshooting expertise in molding defects.
- Knowledge of IQ/OQ/PQ and ISO 13485 or similar standards.
- Mold qualifications (T0/T1, FOT, FAT).
- Background in Lean, Six Sigma, or continuous improvement methods.
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 Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Develop, document, and optimize injection molding parameters using scientific molding principles (RJG, Decoupled Molding, DOE).
- Lead process startups, first‑article runs, and production ramp‑ups.
- Establish and maintain robust Process Development Records (PDRs), standard work instructions, and machine setup sheets.
- Implement advanced process control strategies to reduce scrap, improve cycle time, and increase throughput.
- Serve as the senior technical expert for root‑cause analysis of molding issues such as flash, short shots, sink, warp, burns, and dimensional variation.
- Provide daily production support for molding operations, including tooling, materials, auxiliaries, and automation.
- Mentor junior engineers and technicians on problem‑solving and scientific molding methods.
- Participate in mold design reviews, mold flow analysis, and DFM assessments.
- Lead mold trials, including T0/T1 sampling, FOT, and FAT activities.
- Define and execute tool qualification plans in collaboration with Tooling Engineering and suppliers.
- Lead process validation activities: IQ, OQ, PQ, and documentation per internal and regulatory standards (e.g., ISO 13485 for medical device environments).
- Support nonconformance investigations and implement corrective actions (5‑Why, Fishbone, PFMEA updates).
- Collaborate with Quality Engineering to maintain capability studies (Cp, Cpk) and SPC monitoring.
- Identify and implement productivity improvements using Lean, Six Sigma, Kaizen, and statistical approaches.
- Lead cost‑reduction projects involving materials, cycle time, tooling improvements, or automation enhancements.
- Evaluate and introduce new technologies, equipment, and best practices in injection molding.
- Work with Product Design Engineering to improve part designs for manufacturability.
- Coordinate with Maintenance, Automation, and Production teams to ensure equipment readiness and uptime.
- Support supplier development and qualification for molds, resins, and secondary operations.
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?
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