Process Development Engineer

Description:Key Responsibilities:Process Development & Implementation:Lead the design, development, and implementation of new manufacturing processes and equipment.Specify, acquire, and validate new equipment to support production and process improvements.Problem Solving & Root Cause Analysis:Apply structured problem-solving methodologies to identify root causes of process issues.Develop and implement corrective and preventive actions (CAPAs).Data-Driven Improvements: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.Documentation & Compliance: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.Cross-Functional Collaboration: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.Innovation & Technical Leadership:Evaluate and recommend new materials, tools, and technologies to improve manufacturing capabilities.Support tooling development and process validation for new and existing products.Required QualificationsBachelor’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.Preferred QualificationsExperience 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.Enable Skills-Based Hiring NoStart Time (AM/PM) : 8:00End Time (AM/PM) : 5:00