Process Development Engineer

EQVAL Group, Inc. is a company that provides technical and engineering services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies) and other service companies. We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, to perform and provide a highly effective service. The Process Development Engineer will lead process validation and mechanical design efforts, including IQ/OQ/PQ execution, risk analysis, and process optimization, to deliver compliant, reliable, and high-quality manufacturing solutions. Work Details: Environment: Medical Device / Process Development Validation / Mechanical Design Location: Dorado, Puerto Rico Work Arrangement: Full-time, 100% on-site Qualifications: 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. Minimum 2+ 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. Responsibilities: 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. *Please note that this is a long-term position and requires 100% on-site presence in Dorado, Puerto Rico.* Benefits: Dental insurance Employee assistance program Employee discount Health insurance Life insurance Paid time off Professional development assistance Referral program Vision insurance Work Location: In person