Process Engineers (Validations)

CIS International • Medtronic-Juncos, PR

18d • Onsite

About The Position

We are seeking candidates with a strong engineering background and hands-on experience in regulated manufacturing environments, preferably within the medical device industry. Ideal candidates will have direct experience with process validation activities including characterization, OQ, and PQ (non-cleaning), as well as equipment qualification such as URS, FAT, IQ, OQ, PQ, and TMV (non-laboratory equipment). Experience developing and executing validation strategies, flowing design requirements into manufacturing controls, and supporting design transfer activities is essential. Candidates should also be familiar with risk management tools such as pFMEA, possess basic statistical skills (Minitab preferred), and have participated in project-based validation work that demonstrates practical application of these concepts. Project: 6 new manufacturing lines for a medical devices company in Juncos-PR Responsibilities: This role is focused on building, validating, and enabling manufacturing processes. Generate and execute validation protocols. Perform process characterization activities. Manufacturing process development. Strong candidates will demonstrate a proactive, preventive mindset, with experience establishing process capability, supporting manufacturing readiness, and working closely with MS&T or Tech Ops functions. The emphasis for this position is on upfront process design, validation execution, and ensuring processes are robust, scalable, and production-ready.

Requirements

• Bachelor´s degree in Engineering (Mechanical, Electrical, Chemical, etc.)
• 2 to 5 years of minimum experience
• Experienced with medical devices products
• Process Validation (PV): characterization, OQ, PQ (non-cleaning)
• Equipment Qualification (CSV): URS, FAT, IQ, OQ, PQ, TMV (non-lab)
• Validation strategies & requirements flow-down (design → manufacturing)
• Risk management documentation (pFMEA)
• Basic statistics (Minitab preferred)
• Design transfer activities
• Design requirements validation & manufacturing controls
• Project-based validation experience
• Full time special project assignment
• Full on-site job in Juncos, PR
• 5 months of special project contract
• Administrative and wiling to support non-standard shifts based on project needs
• Availability to start this work on February 1st, 2026

Responsibilities

• Building, validating, and enabling manufacturing processes.
• Generate and execute validation protocols.
• Perform process characterization activities.
• Manufacturing process development.

What This Job Offers

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