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 )

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