Process Development Engineer

Work Details:

• Environment: Medical Device / Process Development Validation / Mechanical Design
• Location: Dorado, Puerto Rico
• Work Arrangement: Full-time, 100% on-site

• Bachelor’s degree in Engineering required (Mechanical, Chemical, or Biomedical Engineering preferred). Other Engineering degrees may be considered with substantial relevant experience.
• Minimum GPA of 3.0 required.
• 5 - 7 years of experience in process validation and mechanical design within regulated manufacturing environments.
• Experience executing process and equipment validations (IQ, OQ, PQ).
• Knowledge of process development methodologies, including DOE, statistical sampling, and process optimization.
• Experience with automated manufacturing equipment and mechanical systems (e.g., laser welding, injection molding, heat bonding, vision systems, PLCs, pneumatics, sensors).
• Familiarity with risk management tools, including PFMEA.
• Strong analytical, problem-solving, and communication skills.
• Ability to work effectively in cross-functional teams.
• Solid understanding of Quality Systems and regulatory compliance.

• Develop, review, and execute process and equipment validation protocols and reports (IQ/OQ/PQ).
• Support qualification and validation of new manufacturing processes, equipment, and products.
• Lead and support mechanical design and process development activities for new and existing processes.
• Generate and maintain technical documentation, including validation protocols, reports, SOPs, manufacturing instructions, calibration, and preventive maintenance procedures.
• Manage process development projects from concept through implementation, ensuring timelines and objectives are met.