Process Development Engineer

Process Development Engineer position in Dorado, PR, supporting IQ/OQ/PQ and process performance qualification activities, and developing validation protocols and reports.

Requirements

• Bachelor Degree in Engineering
• 5+ years of experience in medical devices or pharmaceutical industry
• Bilingual: English and Spanish
• 21 CFR Part 820, GMP, and ISO 13485 regulations knowledge
• Electrical and mechanical engineering applied to automated manufacturing systems
• Automation/controls, tooling, fixtures, test method development, and equipment qualification
• DOE, FMEA, CAPA, and root‐cause investigation

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship