Process Development Engineer

Responsible for designing, developing, and optimizing manufacturing processes to ensure products are safe, effective, and compliant with regulatory standards. Key Responsibilities: Develop and scale up manufacturing processes for new and existing medical devices Design experiments (DOE) to optimize process performance and robustness Support process validation activities (IQ/OQ/PQ) and equipment qualifications Collaborate with R&D, Quality, and Regulatory teams to ensure compliance with FDA and ISO requirements (e.g., ISO 13485) Identify and implement process improvements to enhance yield, efficiency, and cost-effectiveness Troubleshoot manufacturing issues and lead root cause investigations (e.g., CAPA support) Generate and maintain technical documentation, including protocols, reports, and SOPs Qualifications: Bachelor’s degree in Engineering (Mechanical, Biomedical, Chemical, or related field) Experience in medical device manufacturing or regulated industry Knowledge of validation, risk management, and GMP practices Familiarity with statistical tools and continuous improvement methodologies Job Types: Full-time, Contract Work Location: In person