Manufacturing Engineer
Añasco, PR, Puerto Rico
Contracted
Medical Devices
Mid Level
For Engineering services in the Manufacturing area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s degree in Engineering and at least two (2) years of experience within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent communication skills and a positive attitude.
- Shift: 1st and according to business needs.
- Experience in:
- Manufacturing processes, tooling, equipment, and automation.
- Engineering tools: CAD, statistical analysis, root‑cause tools, PFMEA, Control Plans.
- Validation and qualification protocols (IQ/OQ/PQ).
- Lean Manufacturing and Six Sigma concepts.
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)
- Provide daily engineering support to production lines to maintain stable, capable, and efficient manufacturing processes.
- Troubleshoot equipment, tooling, and process deviations using structured problem‑solving methods such as DMAIC, 8D, and Fishbone.
- Own and resolve nonconformances, NCRs, and CAPAs through data‑driven root‑cause analysis.
- Collaborate with technicians and operators to improve line performance and reduce downtime.
- Develop, validate, and optimize manufacturing processes to meet quality and productivity targets.
- Conduct process characterization activities including DOE, MSA, and capability analysis.
- Create and maintain process documentation such as work instructions, PFMEAs, and control plans.
- Lead mid‑size engineering projects, including equipment installations and IQ/OQ/PQ qualifications.
- Ensure compliance with ISO 13485, FDA requirements, and internal quality systems while supporting audits and risk‑management activities.
- Partner cross‑functionally with Quality, Maintenance, R&D, Planning, Operations, and suppliers, providing training and technical guidance as needed.
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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