Process Engineer

• 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.

• 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?

• 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.

Flexible & Integrated Technical Services