Process Development Engineer

a { text-decoration: none; color: #464feb; } tr th, tr td { border: 1px solid #e6e6e6; } tr th { background-color: #f5f5f5; } Position Title: Development Process Engineer Work Location: St. Paul, MN, USA, 55117 Assignment Duration: 7+ months Work Schedule: 8:00 AM - 5:00 PM Work Arrangement: Onsite Position Summary: Lead the design, development, and implementation of new manufacturing processes and equipment. Specify, acquire, and validate new equipment to support production and process improvements. Key Responsibilities: * Lead the design, development, and implementation of new manufacturing processes and equipment. * Specify, acquire, and validate new equipment to support production and process improvements. * Apply structured problem-solving methodologies to identify root causes of process issues. * Develop and implement corrective and preventive actions (CAPAs). * Design and execute experiments (DOE), analyze data, and present findings to cross-functional teams. * Drive continuous improvement initiatives to enhance product quality, reduce waste, and increase efficiency. * Create and maintain technical documentation including SOPs, risk assessments, validation protocols, and safety instructions. * Ensure all processes comply with internal quality systems and external regulatory requirements. * Work closely with R&D, Quality, Manufacturing, and Supply Chain teams to support product development and scale-up. * Provide technical training and mentorship to technicians and junior engineers. * Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities. * Support tooling development and process validation for new and existing products. Qualification & Experience * Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field) with 2-5+ years of relevant experience OR master's degree with 0-2 years of experience or an equivalent combination of education and experience. * Strong analytical and problem-solving skills. * Proficiency in technical writing and documentation. * Ability to work independently and collaboratively in cross-functional teams. * Excellent communication and presentation skills. * Working knowledge of manufacturing systems, automation, and process control. * Experience in the medical device industry, particularly with catheter manufacturing or similar regulated environments. * Familiarity with GMP, ISO 13485, and FDA regulations. * Hands-on experience with process validation, DOE, and statistical analysis.