Process Development Engineer

Process Development Engineer – Contractor (12 Months) Location: Northern Area, Puerto Rico Job Type: Contract (12 months) | Full-time Schedule: Monday to Friday Industry: Medical Devices / Pharmaceutical Manufacturing / Regulated Industry Position Summary We are seeking an experienced Process Development Engineer to support the development, validation, optimization, and implementation of manufacturing processes within a highly regulated environment. The ideal candidate will have a strong background in Manufacturing Engineering, coupled with an academic degree in Electrical Engineering or Mechanical Engineering, and demonstrated experience supporting process validation, equipment qualification, automation, and new product introductions. This individual will work closely with cross-functional teams to develop robust manufacturing solutions while ensuring compliance with applicable quality and regulatory requirements. Key Responsibilities Support process validation activities including IQ, OQ, PQ, and Process Performance Qualification (PPQ). Develop and execute validation protocols, reports, and Master Validation Plans. Design and implement receiving and in-process inspection systems for new products and manufacturing processes. Generate and maintain technical documentation, including: Equipment evaluations Preventive maintenance procedures Calibration procedures Manufacturing instructions and work procedures Lead and support manufacturing process development projects from concept through implementation. Collaborate with Quality, Operations, R&D, Manufacturing, and other cross-functional teams. Apply statistical and engineering tools including: Design of Experiments (DOE) Process Failure Mode and Effects Analysis (PFMEA) Risk assessments Root cause investigations Characterize, optimize, troubleshoot, and improve manufacturing processes. Support implementation and qualification of manufacturing equipment and automated systems. Participate in new product introduction (NPI) and process scale-up activities. Ensure compliance with quality system requirements and documentation practices. Required Qualifications Education Bachelor's Degree in Electrical Engineering or Mechanical Engineering (required). Experience Minimum 5 to 7 years of experience in Manufacturing Engineering or Quality Engineering. Experience working within FDA-regulated industries, including: Medical Devices Pharmaceuticals Biotechnology Diagnostics Technical Skills Strong knowledge of: 21 CFR Part 820 Good Manufacturing Practices (GMP) ISO 13485 Experience with automated manufacturing systems and equipment. Hands-on experience with: Equipment Qualification Process Validation Tooling and Fixture Design Test Method Development Automation and Control Systems Familiarity with: PLCs Servo systems Pneumatics Industrial sensors Vision systems Experience working with manufacturing technologies such as: Laser Welding Heat Bonding Injection Molding Automated Assembly Systems Quality & Compliance Knowledge Proficiency in: FMEA CAPA Root Cause Analysis Risk Management Methodologies Strong technical writing and documentation skills. Preferred Qualifications Experience supporting new product development and product transfers. Project management experience within manufacturing environments. Experience driving continuous improvement initiatives. Strong analytical, problem-solving, and communication skills. Quality Expectations The Process Development Engineer is expected to demonstrate a strong commitment to patient safety, product quality, and regulatory compliance by adhering to all applicable quality system requirements, procedures, and documentation practices. The successful candidate will actively support and promote continuous improvement within the Quality Management System. Apply Today If you are a Manufacturing Engineer with a degree in Electrical Engineering or Mechanical Engineering and experience in regulated manufacturing environments, we encourage you to apply and become part of a team dedicated to innovation, quality, and operational excellence. Job Types: Full-time, Contract Work Location: In person